Pharmaceutical Policy 2002 Insights

Pharmaceutical policy 2002 | Ch-9 | L-2 | Pharmacy Law and Ethics | D.Pharm second year

Estimated read time: 1:20

Summary

Dive into the intricate details of the Pharmaceutical Policy 2002 with Krishna from Mind Nurture. This lecture delves into the historical context, starting from the influential Hathi Committee of 1975, through the evolution of drug policies in the years following, to the significant updates in 2002. Key focus areas include the diversification of the Indian pharmaceutical industry, policy shifts fueled by globalization, and the balance between regulation and innovation. The lecture offers an in-depth understanding of the pivotal changes and objectives that the 2002 policy introduced to address contemporary challenges.

Highlights

The importance of self-sufficiency in medicines was emphasized for national security and economic stability. 🇮🇳
Affordable pricing was a key objective to ensure accessible healthcare for all. 💊
Encouragement of indigenous pharmaceutical manufacturing was prioritized. 🏭
The new policy addressed the needs created by globalization and WTO obligations. 🌐
Liberalization helped in reducing bureaucracy, making it easier to set up pharmaceutical ventures. 📉

Key Takeaways

The Hathi Committee played a crucial role in shaping India's pharmaceutical landscape. 🐘
Pharmaceutical Policy 2002 aimed to modernize and better align with global standards. 🌍
Globalization posed both challenges and opportunities for India's pharmaceutical sector. 🚀
Liberalization in the 1990s set the stage for significant policy changes by 2002. 🔄
Encouraging research and development was a major goal under the new policy. 🔬

Overview

Krishna from Mind Nurture guides us through the substance of the Pharmaceutical Policy 2002, a cornerstone in the evolution of India's drug industry legislation. The discussion begins with a deep dive into the legacy of the Hathi Committee, whose recommendations in 1975 set the precedent for self-reliance in the pharmaceutical sector. The trajectory of policy changes through the subsequent decades showcases India's rise in pharmaceutical capabilities, driven by significant regulatory and structural reforms.

As globalization expanded, so did the necessity for India’s pharmaceutical sector to adapt. The 2002 policy addressed new global challenges and streamlined processes that had previously chartered rigid lines of licensing and trade. Krishna breaks down how the liberalization of the economy in the 1990s carved paths for the deregulation and enabled foreign investments, allowing for a more competitive and resilient industry ready to tackle both domestic and international market needs.

Finally, the lecture sheds light on the specific objectives of the Pharmaceutical Policy 2002. These included enhancing drug accessibility, promoting research and development, and maintaining competitive pricing strategies. With an engaging tone, Krishna underscores the importance of this policy in setting the stage for a future where India's pharmaceutical industry could maintain pace and compete on the global stage.

Chapters

00:00 - 05:30: Introduction to Pharmaceutical Policy 2002 The chapter introduces students to the Pharmaceutical Policy of 2002, as part of a larger discussion in lecture two, following chapter nine. It is led by an instructor named Krishna, who acknowledges the potential confusion among students surrounding the origins and details of the policy. The content is framed within a lecture series by Mind Nurture, aimed at clarifying these policy developments.
05:30 - 10:00: Hathi Committee's Impact on Drug Policy The chapter delves into the role and implications of the Hathi Committee on drug policy. It emphasizes understanding the background and significance of the Committee's recommendations within the context of the 2002 policy. The narrative suggests a need to grasp the objectives and decisions taken under this policy as a foundational aspect for exams and a broader comprehension of its impact.
10:00 - 15:00: Evolution of National Drug Policy (1978-1986) The chapter titled 'Evolution of National Drug Policy (1978-1986)' discusses the significant impact of the Hathi Committee on the development of drug policy in India. The committee played a pivotal role during a period of considerable change in the pharmaceutical industry. Its recommendations were instrumental in formulating the drug policy, which subsequently evolved into what is known as the Pharmaceutical Policy 2002.
15:00 - 20:00: Challenges Due to Liberalization and Globalization The chapter discusses the impact and challenges brought about by liberalization and globalization. It highlights the crucial role of understanding foundational concepts to grasp the implications of these economic changes. A significant focus is placed on the Hathi Committee and its report from 1975, which serves as a landmark in the development of the Indian pharmaceutical industry. Formed in 1974, the committee's recommendations have played a pivotal role in shaping policies and strategies in response to global economic trends.
20:00 - 25:00: Pharmaceutical Policy 2002: Objectives and Challenges The chapter titled 'Pharmaceutical Policy 2002: Objectives and Challenges' discusses the significant growth and diversification of the Indian pharmaceutical industry since 1975, highlighting the industry’s transition from focusing on a single direction to becoming more diversified and vertically integrated. Emphasis is laid on the influence of the Hathi Committee, which has played a significant role in shaping policies and strategies for the industry. The developments in the industry indicate that it is expanding rapidly and becoming a crucial player in the global pharmaceutical landscape.
25:00 - 30:00: Steps and Decisions Under Pharmaceutical Policy 2002 The chapter discusses the involvement of economically weaker countries, particularly in Asia like Nepal, Pakistan, and India, in the pharmaceutical sector as of the 2002 drug policy. Notably, China, rapidly developing at the time, was also part of this scenario. A significant entity, the Hathi Committee, pioneered the implementation of a drug policy, marking a crucial step for these countries.
30:00 - 35:00: Role of PRDC and DPCR in Shaping the Policy The chapter discusses the influence of the Hathi Committee on drug policy. Initiated in 1975, the committee played a pivotal role in shaping drug policies. The transcript emphasizes the committee's foresight in identifying critical focus areas for policy implementation.
35:00 - 40:00: Pharmaceutical Policy 2002: Key Decisions and Regulations The chapter titled "Pharmaceutical Policy 2002: Key Decisions and Regulations" focuses on key aspects to enhance the pharmaceutical sector amidst the growing population. It emphasizes three main objectives: achieving self-sufficiency in medicine production, ensuring the availability of medicines in large quantities to meet national demand, and providing medicines at reasonable prices to ensure accessibility for all citizens. The chapter likely discusses strategies and decisions made in the 2002 Pharmaceutical Policy to meet these objectives effectively.
40:00 - 42:08: Conclusion and Educational Implications The conclusion highlights the need for essential drugs to be reasonably priced, reflecting concerns about poverty and limited economic growth.

Pharmaceutical policy 2002 | Ch-9 | L-2 | Pharmacy Law and Ethics | D.Pharm second year Transcription

00:00 - 00:30 Hello students, welcome to Mind Nurture, I am Krishna, how are you all, great, let's start, today we were reading our next lecture, lecture number two, about whom we were reading chapter number nine in which we have read about NPPA and In this, we have the new heading 'Pharmaceutical Policy 2002'. Okay, children get a little confused in understanding this as to what is the Pharmaceutical Policy 2002, where did it come from, etc. So, we
00:30 - 01:00 will go into the background a bit and try to understand where it is. OK, whose form is this and basically in this we have to remember the objectives and decisions taken under the 2002 policy and go to the exam, but what is this, what is this form, come and understand the 2002 policy. We are trying to do this. Okay, introduction. So son, when it comes to introduction, then those of you who are left here, the children, can remember. Remember, other
01:00 - 01:30 wise, understand where the thing is coming from. We mention the Hathi Committee. Once before also, Hathi Committee has been a very important committee within DPCO, especially at that time when tremendous changes were taking place in our pharmaceutical industry, there was talk of a lot of growth, there Hathi Committee was there. After this, our drug policy is made only on its recommendation. It is fine and the drug policy itself goes ahead, what becomes of our Pharmaceutical Policy 2002.
01:30 - 02:00 If it is clear, then this sequence will remain, so we have to read it, but a little bit about it. You have to understand that when you read these two, the mention of these two comes automatically, so you should know the basic things about them. Okay, then see what the Hathi Committee is saying. The report of the Hathi Committee which it had given in 1975. Okay, it was formed in 1974. This is an important landmark. It is a very important landmark, which we call a milestone. Okay, in the development of Indian pharmaceutical
02:00 - 02:30 industry, son will mark this word. Hathi Committee has a big role. For whom is our OK, for the Indian pharmaceutical industry, since 1975, since that time, the Indian pharmaceutical industries have grown to be the most diversified. Since that time, the industry is big, diversified, meaning earlier it used to move in one direction. What is the meaning of moving, a special one. It is making different types of things, now it has started diversifying, it has started expanding, in a way it is fine and vertically integrated and it was growing very fast.
02:30 - 03:00 We are comparing the farm suit industry in the Antayas. These comparisons are being done by the third world third. Which is the world? Economically weak countries are just like Nepal, Pakistan, India, aren't the Asian countries? Some countries are economically weak countries. China had also come within it, it was growing very fast at that time, so there was a very big elephant committee there. The idea of drug policy was implemented by the Hathi Committee for the first time. Drug policy was brought for the
03:00 - 03:30 first time . It was mentioned that the idea of implementing it was given by this Hathi Committee itself and the drug policy was also implemented in the future. Okay, we will see it now. The Hathi Committee said, brother , what things do we need to focus on at this time? Since 1975, the Hathi Committee has been saying that if we
03:30 - 04:00 look around, do surveys, look around ourselves and as our population is increasing, we have to focus a lot on three things: self-sufficiency in medicines, self-sufficiency, sufficient We should have enough medicine of our own in large quantities to be able to provide medicine to our population in sufficient quantity. Okay, next now there should be availability at reasonable price and the medicine which we will give in large quantity means we are providing it to the people. Its
04:00 - 04:30 price should be very reasonable, okay, it should be okay, it should not be very high, because at that time we can see that even in today's time, many people, what they say, fall below the poverty line, so at that time, the condition is very bad. It was bad, people were very poor and there was not as much growth and development as has happened now. Okay, so a reasonable price of all the essential drugs. All the essential medicines have to be provided at a reasonable price. Second focus, third focus, Indian Indian
04:30 - 05:00 . Swadeshi Indian meaning Swadeshi Encouragement of Self Sustaining of Pharmaceutical Sector is saying that we want medicines and we also have to pay the price but the third thing is that we want that we have our own factories. If it is in India itself then we will make indigenous as encouragement of self sustaining, if we establish our own factory here, then if our pharmaceutical sector in our country
05:00 - 05:30 is focused on three things, it will mark these things, it is okay and for whom was this matter mentioned mainly? Whom does the Hath Committee add to the Indian Pharmaceutical Industries and ask them to implement these things for them? That is fine. Now what happened because of the suggestion they gave, it gave a way to grow the pharmaceutical industry in these given directions and Even if it was implemented later, what happened to it? Our industry started growing very fast. Third World Third World started growing. Again
05:30 - 06:00 I am saying three worlds. Now the countries in the full sense have been divided into three worlds . Look. The same thing always comes up as to how the world has been divided, developed is absolutely right isn't it and there is a second world, probably which country comes in it, I don't have any idea, this is a little GK question and the third world is economically weak. Countries are fine. In between comes the second world. They say that I don't have the slightest idea about it. You guys can check. Okay, then what are you saying? Point The First National Drug Policy. Now if all these things are done then the first
06:00 - 06:30 drug. The policy was declared in 1978. Well, what happened because of the Hath Committee, first the drug policy comes in 1978 and then it is revised in 1986, in 1994 and finally in 2002, so we have our 'Yeh Kya Hai' in the syllabus which is from 2002 but We will understand a little bit what were the things which were revised in 1986, which is a little important to understand the concept of 2002. The story is understandable.
06:30 - 07:00 Hathi Committee I Industries is growing, it gives some recommendations. If a recommendation is given then what is applicable? If the drug policy is implemented then let us first understand what all the things were said in the drug policy. Okay, the same things will come up in our 2002 policy and some extra things too. Okay , now I am understanding the point, let's now silent feature of 1986 drug policy, when the drug policy came in 1986, what were the special points in it, ensure abate availability
07:00 - 07:30 at reasonable prices, the same issue came that to ensure abate availability, abate means too much. Making the essential and life saving and profile elective medicines available in quantity at a reasonable price and also at abate means that there should be no shortage of medicines. This should not happen. It is okay. Emphasis should also be given on the strength, the quality of the drug, it is okay. Stand the quality of drug production. It
07:30 - 08:00 is obvious that the quality of the drugs we are making should be good. It does not mean that we are making them but it should not happen that we get defeated at the international level. And Promotion of Rational Use of Drugs. So son, we will mark these things, the policy of 2002 will be repeated there, these things are correct, what has to be done in the country is the quality of drug production and rational use of drugs, it has to be implemented, one of its objectives has been that its drug policy of 1986. Creating an environment for new investment in the
08:00 - 08:30 pharmaceutical industries. This kind of environment should be created. This will be done by the government itself. Some restrictions will be loosened in some things which are very tight. They will be given some relaxation in the policies etc. so that What should people do? Invest. Those who are rich are rich people. It is obvious that they should show their interest by coming into the pharmaceutical industry and create an industry. Cost effective production. What should our production be like? It should be cost effective so that medicines are available cheaply. Ho Introduce
08:30 - 09:00 new technology which is a new technology which is developed in other countries etc. then what should be done immediately about it? Production of drug should be introduced in our country. Ok this will be a sentence in one line Introduction new technology and production of drug which is new technology and There is production of new drugs, isn't it? Whatever is discovered remains in other countries, what happens to it in our countries immediately? Production should start, isn't it? Suggestion to create a National Drug and Pharmaceutical Authority, is
09:00 - 09:30 n't it the pharmaceutical authority which we have just read, so that is why We had mentioned this there also, when we were studying DPCO, National Drug and Pharmaceutical Authority as an Advisory Body, it said, brother, there should be an authority which will keep advising the Central Government, what steps do we have to take in the matter of drugs and What is the current scenario going on according to which we have to take things forward Next point
09:30 - 10:00 What was it to encourage GMP GMP Good Manufacturing Practice came from here And to give GMP certificate to the formula and along with it GMP will be followed and checking will be done and those who are making proper medicines will be given GMP certificate so that their value will increase brother GMP certified ok this will automatically increase the confidence GMP certified see If it is GMP certified, then if there are others in the market that are GMP certified, then this product is good. The formulas and institutions are OK. They have proven
10:00 - 10:30 expert people. There is a proper testing facility and the medicine is being manufactured in a proper manner. If they are also given GMP certificate, what will happen with this? We will get encouragement that if we make good medicines, we will get GMP certificate. If we get GMP certificate, our medicines will be sold more in the market. Are you understanding the concept of Revision and Issue of a Drug Price Control Order? Keep revising the DPCO from time to time and encourage. Research and Use of Generic Name: Promotion of research and promotion of generic names, nowadays
10:30 - 11:00 we see so much in the market, medicines with generic names are less and more than brand names, okay, so somewhere this is the encouragement research. And Use of Generic Name: All this was said in the drug policy which was revised in 1986. All these things were said somewhere in 2002 and apart from that some other things will also be there, okay? So till now we have understood the matter, now let's talk about the Pharmaceutical Policy 2002. If you understand,
11:00 - 11:30 there is the Hathi Committee recommendation, the policy of 86 is made, after that we come to 2002, okay, see clearly the basic objective of the government policy. It is clear that the Basic Objective of Government's Policy Relating to the Drugs, the basic policy made by the Government regarding drugs is correct, all those things regarding drugs and pharmaceutical sector have been explained in the Drug Policy of 1986. Things
11:30 - 12:00 have been said, okay, when all the things are available there, then what is the need of Pharmaceutical Policy 2002, let's see, okay, now we had to come out from here also, we had some things which were not discussed here in 1986. Was getting it because gradually we were moving towards modernization and a lot of changes were coming in things and technology. Okay, so let's see today to find out what were the obstacles due to which the policy of 1986 was not able to fulfill. How Ever Saying Although The Drug and
12:00 - 12:30 Pharmaceutical Industry in the Country Today Faces a New Challenge Well it is saying that in 1986 all the things are almost mentioned but let's talk about today. If we talk about today's era then it is facing some new challenges. Who is the pharmaceutical industry and that challenge means a kind of say, what are the obstacles, okay, how will those obstacles be overcome, let's see, okay, why are these challenges and obstacles coming,
12:30 - 13:00 on account of liberalization of the Indian economy? Okay, the liberalization of the Indian economy. In a way, say that the very strict rules and regulations were being loosened a little. Okay, the globalization of the world economy. What is happening to the world economy? Globalization is taking place in a way. Meaning economy, the entire world's economy is getting globalized, everything is becoming interconnected with each other and on account of new obligations , obligations are compulsions, new obligations compulsion means you have to do that work,
13:00 - 13:30 why do you have to do it because you have done something. What has been signed? What has been signed ? Under Taken by India under the WTO agreement, that is, the World Trade Organization agreement, there were some obligations under which we had to work, so these are some new things that came out. Under which, in the current era, i.e. if I am talking about the time of 2002, then at that time, some things were facing challenges, some things were facing difficulties, some things were
13:30 - 14:00 facing problems, which is very much right. Now I have understood that the drug policy of 1986 was not being implemented in accordance with the rules. Now it has been understood that ten challenges require a change. Now these are the challengeable ones in the current pharmaceutical policy. In a way, the current pharmaceutical policy was a drug policy. There are some changes in it. And the need for new initiative and some new initiative, what does it say? There was a need for a new initiative,
14:00 - 14:30 beyond what is mentioned in the 1986 drug policy. Beyond that, there is a need to take some new initiative. The age was modified in 1994, which was slightly modified in 1994 and was also revised after 1986. Now understand all these things. There is a reason coming out here that despite being 86, why 2002
14:30 - 15:00 is coming, I am understanding the thing, let us come forward now let us see the effect, we had said one thing here that the account of Liberalization of the Indian Economy. The Indian Economy is being liberalized. What is the meaning of Liberalization ? There are very strict laws which are being relaxed a little. It is being liberalized. What is its effect? So see what it is saying, the process of liberalization has been set in motion. This process of liberalization was set in 1991, which means it had started because
15:00 - 15:30 looking at the all over world, we also had to uplift our industries which have been significantly reduced. The Scope of Industrial Licensing i.e. what was Industrial Licensing earlier? If you want to enter the industry, there was some Industrial Licensing process which you had to take, then it has been reduced to a great extent that now there is no need to take a license, right. Many non-tariff barriers have been demolished and dismantled. Non -tariff barriers to imports,
15:30 - 16:00 to a large extent, have been demolished. The non-tariff barrier which was a kind of tax was abolished. Important steps have already been taken in this regard and under this, the important steps taken under liberalization are as follows: These steps will also be included in the policy that will be made in the future in 2002. Will be included, that is why I am mentioning here that we are fine with the liberalization that happened in 1991. Why was there a wait till 2002
16:00 - 16:30 ? Under the liberalization that happened in 1991, some steps were taken. It is already ok, what steps were taken? Industrial Licensing. For the manufacturing of all drugs and pharmaceuticals, it has been abolished that if you have industrial licensing and not an industry factory, industrial licensing is a process of getting a license, if you are manufacturing any drug or producing any pharmaceutical, then the license has to be taken for that.
16:30 - 17:00 There was a lot of hassle in getting it, there used to be a big process, so now a person can immediately come and set up his own industry, but under whom was this licensing abolished? Within all bulk drugs and pharmaceuticals. But under what was the approval for bulk drug production using Recomin DNA technology? The industrial licensing for the medicines for which Recomin DNA technology was being used
17:00 - 17:30 was not removed, right? In Vivo Use of Nucleic Acids: If nucleic acid is being used to make any drug, then this licensing was not removed for it and it is specific cell and tissue targeted formulation, that is, we can simply say that whatever biomolecule is used. Bio molecule was RNA, DNA or DNA, it became nucleic acid, it became cell or tissue, it became bio molecule. Wherever these medicines were being used,
17:30 - 18:00 this licensing was not being removed. After all, all the other artificial chemicals were our own. That is, except these, all the remaining chemicals were licensed, so that the process becomes easier. Next comes the reservation of five drugs for manufacturing by the public sector. Earlier it was such that five medicines were manufactured only by the public sector. That is, they will be manufactured by the government so that they are available free of cost and can be made available to the public.
18:00 - 18:30 Earlier, what were the five drugs that were only manufactured by the public sector was abolished, which means that this rule has also been abolished. Now the medicines which were made by the public sector were the same medicines, they could be made by the private sector also, okay, this thing was also abolished with effect from Feb 99. Foreign investment, which used to be foreign investment, was Indian and the pharmaceutical industry was included in it. The companies that are set up through joint ventures are meant to be established. In the pharmaceutical industry, we are talking about
18:30 - 19:00 foreign investment through automatic route which was raised from 51 per cent to 714 per cent, which means that a factory is being set up. An industry is being set up, it is okay, it means the whole industry is being set up, a factory is being set up, suppose someone is setting up a company, but suppose a company worth ₹ 1 is being set up, then the ₹ may seem to be from a foreign country. And the rest of the Indians will be allowed a maximum of 74, not more than that, okay? And earlier, the foreign fund was allowed only at 51, not more than that, okay.
19:00 - 19:30 By March 2000, the same has been increased to 100% and finally it was said that brother, because looking at the economy of India, there was not that much money, it is okay, you have to do it, you can have 100% foreign investment, okay . Automatic Approval for Foreign Technology Agreement: Foreign Technology Agreement means that the foreign technology is okay, the agreement was there for it, Automatic Approval means that if there is any technology in a foreign country, then it is automatic, what will we do with it, will we
19:30 - 20:00 use it in India, can we bring it, being given in the Case of Bulk Drug: The matter of bulk drug has come again. This was applicable for the above mentioned bulk drugs, but it is okay, bulk drugs, their intermediates and formulations are accepted, that is, the above mentioned medicines were the same, in the same manner for bulk drugs and pharmaceuticals. So foreign technology was applicable but it was produced using recombined DNA technology, in which the same biomolecule is being used, whether RDNA
20:00 - 20:30 is being used or tissue is being used, nuclei are being used, this technology will not be allowed for them, right? For which the procedure prescribed by the government would be followed, then the procedure adopted for that will be brought. Okay, so that is, see what it is saying, automatic approval, that is, automatic approval of foreign technology will be done. You call technology I. There will be a form and it will be filled automatically, you can use it, there is no need to take permission from some government, but if you
20:30 - 21:00 are making these types of medicines of RDNA type, then you will have to go through the process and take government permission. Understand this. It is coming that we can directly use foreign technology in our country without the permission of the government. This is automatic approval. For that, if you understand the point, then understand it, son. What came from the elephant committee, the elephant committee. 1986 Drug Policy came and there were some shortcomings in the drug policy also because liberalization was taking place, so under LILA, some steps were taken, which
21:00 - 21:30 were very good steps, but there were some shortcomings in this too, meaning, some steps were left less. Those who will finally come in 2002, come forward, what is the next step? All these steps will also be included. Let's understand the next step. What is drug and pharmaceutical manufacturing unit in the public sector, which is public sector i.e. government, which is the manufacturing unit of drug and pharmaceutical. Allowed to face are being allowed to face competition including competition from imports. It
21:30 - 22:00 is okay that their competition has also been allowed, that is, what was earlier was good, if it is government, then their competition will not be kept, but now they have also been put in the competition. Brother, do it, give good performance to others. If you do better than this then it is okay, otherwise it is not okay, but it is ever possible that these units are being privatized and as far as possible, what was done to the non-government or public sector manufacturing units, they were merged into the private sector. Okay, this is the introduction
22:00 - 22:30 of the patents, okay, what was the Second Amendment? Earlier, there used to be some problems regarding patents, so now what have you done that if you have made any discovery while living in India, you have patented it, brother, what is the meaning of making a discovery? Lakhs and crores. If trillions of rupees are spent, how will it be recovered? That's why the bill says that if you get a patent, then a bill has been passed which is amended, 'Inter alia' means in this bill, apart from this, it provides for the extension of life of patent or The simple
22:30 - 23:00 thing being said is that if you make a discovery and get a medicine patented, then you will have the right to sell that medicine for 20 years and that will be yours only. If no other company will sell it, then it is obvious that if that medicine is consumed in the entire country, then how much profit is there, but before that, what is the benefit of researching it? The benefit that people are getting from this is that people are involved in research and development. Will invest money so that I can discover some new medicine? Well then the profit is mine. If you understand the point, then in a way the life of the patent has been extended, which
23:00 - 23:30 has been increased to 20 years. If things are clear, then any more points. It is okay, so by now you must have understood that what steps were taken to cover up some of the effects that came due to liberalisation , important steps were already taken in this regard, so all these Steps have been taken, I understand, come on now, what happened, let's come next, Why Pharmaceutical Policy
23:30 - 24:00 2002, when those steps were taken, 199 in that, the liberalization that was happening in that forest. Once the steps were taken, things calmed down to a great extent, but then what is the need of 2002, so let's see ultimately what is being said, okay, how ever, however, two major issues have surfaced, two major problems, surface, surface, meaning, have emerged on account of. Globalization Globalization means
24:00 - 24:30 what do we do with the whole world? In a way the whole world has merged into one. Okay, when globalization happened, what was happening to this industry pharmaceutical industry because of it. If globalization was happening, then what does globalization mean, are other foreign companies here ? The companies here can come and go out. Globalization is happening. Two problems have surfaced. Two major issues have surfaced. Still despite doing all that, is it okay? End Implementation of our Obligation under
24:30 - 25:00 Trade Related Aspects. What do we call Intellectual Property Rights Trips and what do we say? Sorry, the Trips were implemented. Trips means Trade Related Aspects of Intellectual Property Rights. What does Intellectual Property mean ? In a way, like our pharmaceutical industry which is intellectual, what is happening here? Research is being done, right? Bio molecules are being used, DNA is being used, so it comes under intellectual property. If you understand this, then what was the reason for this? A kind of
25:00 - 25:30 elixir trip that happens. Under this, there were some obligations. There were some compulsions. Okay, so looking at that, what is the impact on long term competition of Indian industry. So firstly, what was globalization and secondly, what was the trip due to this, which is the long term competition of Indian industry, which is if we compete. So there were some problems, these have been addressed in the Pharmaceutical Policy 2000. This has been addressed and resolved in the Pharmaceutical Policy 2002, that
25:30 - 26:00 is, the above points will also be covered in this in 2002 and these two points have also been resolved. Will come, understood the matter within this, okay then why was there a need for 2002, this is the reason for 2002, right? Reorientation of objective of the current policy orientation means that the objective which was back then has been reoriented.
26:00 - 26:30 In a way, we can say that it has been renewed, okay, it has also become necessary on account of these issues, so what we are saying is that it is a renewal, which were the old objectives, which we had read in the drug policy etc., which were the objectives, in a way, theirs too. Renovation was necessary in view of these problems. Okay, now what is being said next on account of these issues. What are the issues? Two issues are written here: The Essentialist Incentives for Research and Development in Indian Pharmaceutical
26:30 - 27:00 Industry. Look, what was globalization happening? Foreign. People are coming, okay, foreign companies are coming, so that brother, we have to provide medicines to our people, if the people of our country will not do it, then it is a compulsion, what will be done, help will be taken to the foreign people, if help is taken from abroad, then what for that? Gaya The Essentialist Proving A need, what needs to be improved, what needs to be improved, incentives, means a kind of funding, whom to fund, money to be given for research and development, which is India's R&D. To give incentives to the Indian
27:00 - 27:30 pharmaceutical industry means to provide incentives, to fund a fund, to provide money from the government so that it can invest in research and development, that is fine, it will be taken as a loan, it will later be returned to the government, but help has to be done. It is important for the government to ensure that R&D flourishes in our country to enable the industry to achieve sustainable growth, especially in view of anticipated changes in the patent law. Okay, so what will happen if we
27:30 - 28:00 give incentives and do a little funding for research and development? What will happen in development, what will be the help to the industry in maintaining its growth, why selling something is a different thing, making something, but after researching something, then one gets dominance over it, one gets authority over it. No, no one can sell it all over the world except that company. If you have discovered a new molecule in the whole world, then you can sell it all over the world.
28:00 - 28:30 After getting the pattern done, there is research and development somewhere for this. There was a need to provide incentive funding. Okay, the need for reduce further and riggers. Sorry, the need for reduce further. Then the next need was the power that was there in the riggers of price control, which was DPC and not price control. Riggers means power in a way. Neither was the tightness that was there, it needed to be reduced a bit. Special in view of the on-going process of liberalization, now in our own country, if
28:30 - 29:00 our own company, our own people will not be able to establish a factory, they will face problems, then how will the work be done, then because of that, what was there in the price control, what power was there. It was reduced because brother, it is obvious that when foreign medicines will come, they will be taxed, they will be a little costly and we are hoping that if the people of our country sell them cheaply, then they will also earn a little profit. Okay, not too high, okay, the prices will remain the same, it's okay, so looking at all these things, you must have understood what happened in the policy of 2002, that the policy got stuck. Okay, now see, if
29:00 - 29:30 the question comes in the exam, then you will almost understand the story. If question comes on 2002 drug policy then what is the drug policy? You can mention it here a little or make a small summary from the above theory. Otherwise, where directly? The main objective will come first. What will you write about the main objective of this pharmaceutical policy 2002? Why was it told? Where was the orientation here? Where was the review done? Some of the old
29:30 - 30:00 points were also kept. Some new points were also kept. So what were its objectives? The first point is the same as it was earlier i.e. Insurance of good quality of drugs and pharmaceuticals at reasonable price in the country. That point has arrived in our country in adequate quantity and at a reasonable price. The second strength that should be available is the capability for cost effective production. We have to strengthen
30:00 - 30:30 whom we have to strengthen so that the production that we have in our country should be good in quality and at the same time it should be cost effective and also be cheaper. Next What was the point: Creating an encouraging environment and good network for introduction of new drugs. It is okay to create such an environment and create a good network so that new drugs can be easily introduced in our country which is discovered in foreign countries. It is okay. And technology
30:30 - 31:00 can be easily introduced by insurance. Tomorrow the industry is fine by insurance. Only when there is new investment, only then the medicines and technology from outside will come to India. OK, encouraging export of drug drug formulations. The medicines that we are making should be made in such large quantities that our country That it is good for the people, it means that they get adequate quantity, we can also export it by reducing barriers to the trade in pharmaceutical sector. Trade means that there is a lot of power regarding the medicines that we sell abroad.
31:00 - 31:30 The barriers are very high. Right, go here, go there, this form, that form, check here, check there, all these things happen, we have to reduce them a bit, promoting rational use of pharmaceuticals, this was the point, the strength, the system of quality control of drugs, right, and pharmaceuticals. Quality Control: Drugs and pharmaceuticals should remain under quality control. Encouraging R&D Research and Development Ventures. Ventures means that we are with someone,
31:30 - 32:00 we have money, someone has brains or we also have money, someone else also has it. There is money, both of them will open a research together and R&D will do research there. Okay, R&D ventures in pharmaceutical sector especially with focus on diseases endemic and relevant to India. Diseases endemic and relevant to India means we have to do research and development on those diseases also. The disease which has to be done above is endemic which is found in large quantities at many places in our country or
32:00 - 32:30 the disease is relevant to our country. We have to do research on it first so that medicines can be found through new discoveries. The meaning of discovery is this. It happens that the medicine should be very effective and cheap. Okay, so this is its objective. You can see somewhere that the objective was the same as we read above. Okay, so the story above is there, we need to understand what this 2002 policy is. Is there any other way, what will you write directly from here? When your question comes, you will write the objective directly from here. I have understood the point,
32:30 - 33:00 okay, this was the objective, but what decisions were taken under this policy, what was decided about this policy? What will be those decisions under that, let's talk about some things that happened before that decision, what things happened, the approach adopted, adopted in the review means what approach and method was adopted before taking that decision, then when that decision is taken i.e. again when the 2002 policy. If we talk about these points also
33:00 - 33:30 It is mentioned, okay, what is the point? Pharmaceutical Research and Development Committee (PRDC) will also be mentioned when you talk about 2002, because the suggestions of this committee were also included in 2002. Okay, so it is being said in this order. Strength the Pharmaceutical Industry Well, to strengthen the pharmaceutical industry, Research and Development Capabilities, and to identify
33:30 - 34:00 , Strength the Pharmaceutical Industries, Research and Development, to strengthen , and to strengthen the pharmaceutical industries, Research and Development, and Two identification support is needed so that it becomes the best in the world. It is understandable
34:00 - 34:30 that two undertake domestic research and a committee was set up keeping in mind what should happen in our own country and the research and development of the famous industry. And what kind of support do they need to do all this work? A committee was set up in 1999 by this department by the name of Pharmaceutical Research and Development Committee PRDC under the Chairmanship of Director General CSIR to qualify SRND Incentive Intensive. Well, he said that when this committee was formed and everything was surveyed,
34:30 - 35:00 what did they say? The conclusion that came out of this committee is that if you want to become an R&D intensive company in India then there is the PRDC. Suggested the following condition which we also call gold standards. He said that we will support and do everything. If you want to become an RND company and the company is to be established as an RND company in India, then there are some conditions. What are the conditions
35:00 - 35:30 on Invest Atlist 5? Nm in RND on its turnover i.e. if the company is earning 00% of its turnover, then ₹ has to be invested in RND, only then that RND will come inside the company. Invest Atlist 10 Crores Nm in Innovative Research. 10 crore rupees are to be invested every year in innovative research including new drug development, new delivery system etc. Is there any new drug development or new delivery system in India
35:30 - 36:00 ? Any medicine which earlier we used to take only through a different route, can be given by injection. You can also give some meaning through this type of innovative research, you have to spend Rs. 10 crores, employ at least 100 research scientists in RND in India, you have to employ at least 100 research scientists in your RD, which is India. Has not been involved in outside R&D Has been granted At least 10 patents for research done in India Is it okay and has done at least 10 patents for research Own
36:00 - 36:30 and operate manufacturing facility in India Has his own ownership The manufacturers who make medicines are okay, they should also have their own factory to make medicines, they should also have Establishment of Drug Development Promotion Foundation DD PF and Pharmaceutical Research and Development Support Fund PRD SF. So he said, all these things will remain okay and together. Establishment of Drug
36:30 - 37:00 Development Promotion i.e. he asked for establishment of another foundation, Drug Development Promotion Foundation, DDPM, Pharmaceutical Research and Development Support Fund, PRD SF, this too, that is, this point should not actually come within it, it will remain separately, okay, then this So it was for the company and it was also that it should be formed. This is understood by PRDC. So research and development had to be promoted somewhere. Maximum research and development
37:00 - 37:30 should be done in our country only. It is understood. Well, one thing is that the Pharmaceutical Research and Development Committee is right, one is that its review was kept first and whose review was kept, and whose views were mentioned in the drug policy, the second was the Drug Price Control Review Committee DPCR. In order to review the current drug price control mechanism. In order to review the current drug price control mechanism. In order to review with the objective
37:30 - 38:00 . All its work is to reduce the rigor of price control, which had too much power over price control. It is okay to reduce it where it has become counter productive. It is okay that there was price control. What is its objective? What is the issue with this committee? What was the issue of reviewing the drug price control mechanism, how the drug price was controlled, what was the mechanism and what was its purpose, its purpose was that the power which is drug
38:00 - 38:30 Where is it being counter productive in price, that is, it is creating opposition in production, okay, a committee had to look at this, in view of that, there was a committee called Drug Price Control Review Committee, so what was the purpose of this, which is Drug Price Mechanism. Its job was to see how it is creating opposition in our production. Okay, under the Chairmanship of Secretary Department of
38:30 - 39:00 Chemical and Petrochemical was set up in 1999 which has given its report. He also gave his report the recommendations of DPCR has been examined and taken into account, that is, it has also been taken into account, that is, it has also been taken into account in the formulation of the Pharmaceutical Policy 2002. Till now the matter has become clear, then who all had a hand in the formulation of the pharmaceutical policy, and what things had a hand in it . All the terms come in it, okay, one marks question will come from DPCR, suddenly it will come in one marks, where did it come from, it is not in the syllabus, so it
39:00 - 39:30 also has points in it, okay, whatever was there before that, what do you say? This was PRDC, it also has a role in it, drug policy also has a role in it, so everyone has a role, son, everyone should know the basic basics. If direct question comes in the exam, write a short note on Pharmaceutical Policy 2002, then you can tell directly. I have already written about what you will do, directly write its objective and after writing the objective, okay, this is all the points in view of
39:30 - 40:00 the steps already taken and in the light of the approach indicated in the for going paragraph. In the view of the steps already taken And in the light of the approach and the above approach indicated in the for going paragraph above The Decisions of the Government Under Pharmaceutical Policy 2000, give more details, what is its decision, then if you want, you can directly write Decision,
40:00 - 40:30 Under Decision of the Government, Under Pharmaceutical Policy 2002, you can directly write by putting this heading, there is no need to write the above line. I wrote the above line here and told you that these things have had an impact on 2002, but I understand this. Okay, now see what all the things will be like. If all the points mentioned above will be included here, then what? -What has come in the Pharmaceutical Policy 2002, what decisions were taken, industrial licensing for all bulk drugs
40:30 - 41:00 was created by the Drug Controller General of India, that is, whatever licensing was there is fine, all that was cleared for industrial licensing of bulk drugs. Shell B Abolished Except what? Drug produced by Recomin DNA technology and bulk drug requiring in vivo use of nucleic acid, that is, it is obvious that where nucleic acid or cell tissue is being used, it is fine except that. What has been done to all the others? Industrial licensing has been abolished, so this point has come, it has become easy, now foreign investment will be 100%
41:00 - 41:30 permitted, okay, final, now this policy has been framed, this point of ours has been said, now that is okay. These final things were objective. Import of drug and pharmaceutical will be the age as per the agem policy. He said that the import and export that will remain is the export-import policy which we have read. What is the fourth saying ? Is there automatic approval of foreign technology agreement? If there is any foreign technology then it gets approved automatically, you will
41:30 - 42:00 use it, just tell that yes, you are using foreign technology, your automatic will be approved, you are fine not to do anything, it will be available. In the case of bulk drug cleared by the Drug Controller General of India, it is okay that you have also been told that all their intermediates and formulations, that is, all the intermediates of bulk drug and their formulations, you will get automatic foreign technology approved, except whom. Except where you cannot use foreign technology directly, where you have to take permission to use fun technology, drug produced by Ramne DNA technology and bulk drug
42:00 - 42:30 requiring innovative use of nucleic acid, that is, the same thing where rDNA technology and nucleic Acid is being used there, many of the things which we have read above are old, if you want, you can fast forward a bit and watch the video. Okay, Establishment of Pharmaceutical Research and Development Support Fund PRD SF, where did this come from now? It was above this it was recommended Above this, there should be a fund from PRD, under the control of DST Department of Science and Technology, an established
42:30 - 43:00 Pharmaceutical Research and Development Support Fund, that is, there should be a fund to support pharmaceutical research and development. There should be a constitution which will control DST will control Constitution of Drug Development Promotion Board to administer Utilization of PRDS PR DSF Formation of a board named Drug Development Promotion Board There will be a board to promote the development of drugs Drug Development Promotion The board that will administer
43:00 - 43:30 the utilization of PRDS F means what will be done about the utilization of the funds that are coming, that is what the administrator does, that is, investigation address, that is, all the things will be under it, provision of fiscal incentive, fiscal means financial, fiscal means financial to promote Indian R&D efforts. In whatever indigenous research and development is being done, giving financial support incentive is an incentive. What is called a kind of thing is called a kind of thing. Giving a price is a kind of saying that if you do this then we will do it for you,
43:30 - 44:00 isn't it? It is of this type and I am telling this to explain that it is okay, here the incentive is given in the form of money. 279 Items Appearing in National Essential Drug List 1996 of Ministry of Health and Family Welfare is okay, which is 279 Drugs were in the National Essential Drug List in 1996, okay, now this National Essential Drug List, we will study it in detail in the next lecture, okay, in 1996 of Ministry of Health and
44:00 - 44:30 Family Welfare and other 173 items considered important by the same Ministry in Various Health Program, Emerging Geriatric Care Shall Be For Price Regulation, So you will just write here that the 279 items which were in the Sense National Essential Drug List in 1996 are okay and the 173 items which were okay in the Family and Other 173 items which What has been done was considered important and they
44:30 - 45:00 were booked under price regulation that price regulation will be imposed on them, it is a simple thing, or else a line will be made directly here that price regulation will be applicable on the National List of Essential Medicines. Simple thing, for the imported formulation which is being imported, it is being brought from abroad. The margin will be there to cover the selling and distribution expenses. Brother, we bought something from abroad for ₹ 1, it is okay, we have to sell it, we have to distribute it. Including interest and
45:00 - 45:30 importers profit all over India. So it is said that you are bringing something from abroad and are selling the medicine, you have to sell it and also distribute it and along with it, the interest in it and the importers profit which is there. His profit by importing is that all of them put together should not exceed 50% of the off the land cost i.e. if he imported something here from our foreign country and by doing so, what did he incur, how much did he incur, how did he incur the cost of Rs. Suppose it is said that
45:30 - 46:00 the suppoj brought the duty tea from there, he paid all the things for Rs. 00, then he has to sell it further, he has to do all the work, then he is saying that it will be the land cost, the price he would be paying for bringing it here from abroad, how much will he pay only for it. It is % i.e. if you have brought an item worth Rs. 00, then you will be able to sell it only for Rs. 150, you will not be able to sell it for more than that, okay, what will happen if it is a foreign import, it will get a little less increase in promotion, otherwise will a person keep buying from outside and selling it within himself ? Our indigenous work
46:00 - 46:30 will not be promoted, then what is the Org Marg saying? Look, this is a company, it is a market research organization, it is a Nielsen Org Marg, it is very reliable. Its data is considered to be absolutely accurate. The data should be The Basis for Determine the Span of Price Control He said that what will we consider as the basis for determining the span of price control, the data given by this organization
46:30 - 47:00 is ok, it will be the time of price control, for that we will consider its data. What will we consider as base? Suggested by the Drug Price Control Review Committee DPCR. It suggested that we will accept its data and will not accept anyone else's data. Bulk drug shall be under price regulation. It is saying that bulk drug will be under price regulation. If the moving annual turn turn moving annual total value for the drug is more than Rs 25 crore and the percentage share is more than 50, that is, it is saying that its MT
47:00 - 47:30 value is Rs 25 crore and the percentage share is in a way the market. If the share is more than 50 then it will remain under price control then it is saying that What is the second condition if the total MT value of a drug for a particular drug is less than Rs 25 crores? If it is less than Rs 25 crores but more than Rs 10 crores and its market share is 90, will it be a cheap drug? Any such medicines are also in which category? The price will
47:30 - 48:00 remain within the regulation. This is the decision. Son, you will have to pay these points. Maximum Alabu Factoring Expenses. We have read M.A.P. We will be 100% for Indian. Original manufactured formulation. If you are making indigenous medicine, then on top of that you will give 100% to M.A.P. You can take % i.e. if your medicine is ready for ₹ 10 and the cost to deliver it to the retailer is also ₹ 10, then you can sell the medicine for ₹, the ceiling is fine. Price of any
48:00 - 48:30 formulation may be fixed by us which will be mandatory for all to follow If ceiling price for any formulation is fixed then everyone will have to follow Next A new drug developed through India's nd efforts If any new drug It has been made with the help of efforts of indigenous R&D i.e. with the help of our own research and development. It has been made free from price control for 15 years. Price control will not be imposed on it for 15 years from the date of commencement. Commencement
48:30 - 49:00 means beginning. From the day it starts manufacturing and production in the country, price control will not be imposed on it for the next 15 years. Why not so that it can earn its profit and R&D gets support? Now the formulation is evolving. New delivery system developed through indigenous as R ND and patented shall be enhanced from price control till the expiry of the patent So the same thing comes again, both are same in some way or the other, is there any formulation in which evolve a new delivery system of new
49:00 - 49:30 delivery system What does it mean? Suppose there is a medicine which till now we used to take it in the form of a tablet, now what have we done with it in the form of a cream or in the form of an injection, the delivery system has been changed, its new technology has become This means that a new drug will be created and then it will be in such a condition again that price control will not be imposed on it until its patent expires. We have read the NPPA and we will be authorized to accept the true formulation of the National Pharmaceutical Pricing Authority. This is the NPP, this is the authorisation.
49:30 - 50:00 Authorization will mean that it will give permission to accept true formulation from price control. It will have the authority to say that yes, this formulation is to be exempted from price control or not to be exempted if its cost to consumer patient does not exceed 2 per day. Okay, now leave it. Two, you will get confused here, it is okay, we will keep it till now, the NPPA will be reviewed and
50:00 - 50:30 reorientation and renewal will be done to monitor the prices of D-controlled drugs so that the D-controlled drugs remain under control and formulation and oversee implementation of DPCO is okay. That is to say that there will be changes in it so that the D controlled drugs remain under control and DPCO is implemented properly. It should be mandatory or necessary for the manufacturer to furnish all the information called by NPPA. Whatever information is given by NPPA. The manufacturer will have to give what is demanded
50:30 - 51:00 , they have no choice other than that. The Government Endeavor Endeavor means in a way, the Government will endeavor to upgrade the standard of pharmacy. The Government will endeavor to upgrade the standard of pharmacy. Upgrade the standard of pharmacy education. Will upgrade the standard of pharmacy education. Will keep upgrading ND, that is,
51:00 - 51:30 will keep increasing the quality of its standards. Through whose nose, National Institute of Pharmaceutical Education Research Mohali Punjab is right, which is our nose there. But according to what was there at that time, through this it will keep increasing the standard qualities of pharmacy education and RND, so somewhere it has also talked about education, after all the above things, which were about 19. There are some two or four more points which were from me, so I got these 19 points written here, from here you will remember at least 10 points well and remember the objective which you can definitely
51:30 - 52:00 write in the Pharmaceutical Policy 2002. A little bit of the topic is clear, now look somewhere, if you have heard this lecture, then things will automatically get set in your mind. Friend, all these points are very common, so we will write them, you must have remembered them, so let's read this lecture. Our passes run out ok so what to do as usual You have to study, you have to revise the note, its link will be found in the description, if you face any problem then call me, rest as you all know, the exit exam has now been implemented,
52:00 - 52:30 so what can you guys do, you can join our app. You can practice, okay, it's a lot of fun and the most important thing is to do, you have to revise, you have to study, okay all the best.