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Covid-19: Perils Of Haste In Scientific Decision-Making Process

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Multifaceted threats posed by Coronavirus to the humanity, are getting increasingly complex, every day. Currently, Covid-19 cases in India are ‘the highest that any country has ever recorded on a single day since the start of the outbreak.’ Alongside, the hopes of billions of people – for its predictable and dependable remedies are also soaring sky high. But, despite full throttle global endeavor of scientists, the world continues waiting for scientific-evidence-based, well-proven, safe, and effective Covid-19 drugs, vaccines and other treatments.

It is expected, each of these cures and antidotes should be duly authorized by drug regulators, according to global norms – without any outside non-scientific interference – not even from the very top. Nevertheless, the reality is, as on date, besides some ‘emergency use authorizations’, all scientific pursuits in this area are Works in Progress (WIP) – some are with great potential, though.

The catastrophic impact of Covid-19 pandemic is all pervasive. So is the competition between media publications to attract maximum eyeballs, with details on many aspects of the disease and related scientific development. These include reports on intense, non-scientific pressure on scientists and regulators to make drugs, vaccines or other Covid-19 treatments immediately available for use. In this article, I shall dwell on the perils of haste in the scientific decision-making processes, while combating Covid-19.

A quick research outcome is important – based on ‘rational’ – but not ‘rash’ decisions: 

In pursuit of a quick disease treatment outcome, a rational and ethical approach in any scientific discovery process, is non-negotiable. It has always been so – while dealing with many different health crises, and should remain that way for Covid-19, as well. In my view, for achieving a prompt and desirable treatment outcome – a quick, but rational decision should always be favored – over highly influenced, contentious, non-scientific and rash decisions.

Many wise men believe, a quick decision is one, made quickly supported by irrefutable inputs of an accepted quality and scale. Whereas, a rash decision is one, made with limited, questionable or even no inputs – just based on gut feel, as it were. This broad concept is applicable to Covid-19 drugs, vaccines and other treatments, including -plasma therapy.

In the space of Covid-19 pandemic, there are several such examples, starting from hydroxychloroquine to the most recent plasma therapy – both in India, and also beyond its shores. Without being judgmental, this article will try to join some critical dots, for the readers draw their own conclusions on this issue. Let me start with two examples of this drug regulatory quagmire – the very first, and the most recent ones.

Perils of haste in the Hydroxychloroquine saga:

As I wrote in this blog that the US President Donald Trump, on March 21, 2020,  proclaimed Chloroquine and Hydroxychloroquine as potential game changers against Covid-19 global pandemic, despite doubts from the US-FDA. Interestingly, on March 28, 2020, the US drug regulator granted the emergency use authorization of these two drugs for treating Covid-19. However, it was subsequently revoked on June 15, 2020. The agency justified this action by saying:

“Based on its ongoing analysis of the EUA and emerging scientific data, the FDA determined that chloroquine and hydroxychloroquine are unlikely to be effective in treating COVID-19 for the authorized uses in the EUA. Additionally, in light of ongoing serious cardiac adverse events and other potential serious side effects, the known and potential benefits of chloroquine and hydroxychloroquine no longer outweigh the known and potential risks for the authorized use.”

The World Health Organization (W.H.O) also announced: “Studies show Hydroxychloroquine does not have clinical benefits in treating COVID-19.” However, as published by JAMA on May 28, 2020,following President Trump’s naming these drugs at a press conference, Hydroxychloroquine prescriptions shot up by over 200 percent, over the previous year. Nonetheless, the prescriptions returned to normal as news highlighting the lack of enough evidence to support its use started spreading, across the globe.

Soon, India followed the same… a strange coincidence?

As stated above, on March 21, 2020, the US President Trump proclaimed Chloroquine and Hydroxychloroquine as potential game changers against Covid-19 global pandemic, despite doubts from the US-FDA. Curiously, on March 23, 2020, Indian media also reported:

‘Amid rising Coronavirus cases in the country, the national task force for COVID-19 constituted by Indian Council for Medical Research (ICMR) has recommended hydroxy-chloroquine as a preventive medication for high-risk population. According to the advisory, it should be given to high risk population — asymptomatic healthcare workers involved in the care of suspected or confirmed cases of COVID-19 and asymptomatic household contacts of laboratory confirmed cases.’

The above protocol, recommended by the National Task Force, has been approved by the Drug Controller General of India (DGCI) for restricted use in emergency situations. This seems to have happened even before the US-FDA granted similar authorization. Intriguingly, US-FDA subsequently revoked it on June 15, 2020, for lack of enough scientific evidence, unlike the Indian drug regulator.

Another report of April 09, 2020 summed it up well. It wrote, the hype of Hydroxychloroquine – pushed by the US President Trump as a COVID-19 treatment, has now been joined by many other countries, despite inconclusive medical evidence on the efficacy and safety of the drug. Is this just a strange coincidence?

Be that as it may, India’s decision on the emergency use of Hydroxychloroquine had its rub-off financial impact in the country, in terms of increase in its export demand, which may not be an intended one, though.

Its rub-off financial impact in India:

As the world’s largest manufacturers of Hydroxychloroquine are located in India, many of these companies reaped a rich harvest in the April-June quarter, mostly, based on media reports on its use in treating Covid-19. For example, Ipca Laboratories Ltd, reportedly, garnered ₹259 Crore in additional sales, with consolidated net profit for the quarter soar threefold to ₹454 Crore, from the drug in that period.

Notably, Ipca also acknowledged, ‘HCQ sales were a one-time boost for the company. With the hype waning, after various clinical trials showed the drug did not provide any significant benefit, the company now expects sales to ease to earlier levels,’ as the report goes. Let me now move over to the most recent example.

Perils of haste in the plasma therapy saga:

Since, the third week of this month, a series of incidents related to plasma therapy highlighted the ongoing perils of haste in the scientific decision-making process. These were generally prompted by powerful non-scientific external influences, as reported below:

  • On August 23, 2020, the US President announced that the US-FDA has granted emergency approval of blood plasma from recovered Coronavirus patients as a treatment for those battling the disease. President Trump called the development “a historic breakthrough.”
  • According to Reuters, the US-FDA had authorized its use after President Donald Trump blamed the drug agency for impeding the rollout of vaccines and therapeutics for political reasons.
  • The very next day of President Trump’s announcement, on August 24, 2020, the World Health Organization advised caution about endorsing the use of recovered COVID-19 patients’ plasma to treat those who are ill, saying evidence it works remains “low quality.”
  • American scientists, including researchers at the Mayo Clinic also challenged a key statistic cited by U.S. officials as grounds for emergency approval of the treatment.
  • On August 25, 2020, US-FDA Commissioner Stephen Hahn, publicly apologized ‘for overstating the benefits of plasma for treating Covid-19 patients.’ 
  • “The US-FDA’s emergency use authorization for plasma for Covid-19 looks questionable. If this presages an early vaccine nod, we should be very afraid,” reported another article.

Similar controversy was also witnessed in India. Just days after the Drug Controller General of India (DCGI) gave its go-ahead to a proposal of ICMR for the clinical trial of convalescent plasma therapy in COVID-19 patients, the Ministry of Health said, ‘there is not enough evidence to claim plasma therapy can be used for treatment of COVID-19. Interestingly, several states, such as, Delhi, Gujarat, Maharashtra and Uttar Pradesh, have already started clinical trials for plasma-based treatment. Meanwhile, media reports, such as, ‘India sees black market boom for plasma from recovered Covid-19 patients,’ started pouring in.

Conclusion:

As recorded in the morning of August 30, 2020, total Coronavirus cases in India have reached a staggering figure of 3,542,733 with 63,657 deaths, despite all measures taken by the country. No signs of flattening of the curve are visible, just yet. In this situation, many experts believe, the way prescriptions are written for Covid-19 patients, based on anything but robust considerations, needs to be re-looked. The headline of an article, written by Richard L. Kravitz, Professor of Health Policy and Internal Medicine, University of California, Davis on July 09, 2020, vindicates this point. It said:‘When Trump pushed Hydroxychloroquine to treat COVID-19, hundreds of thousands of prescriptions followed, despite little evidence that it worked.’

Another interesting article, tried to ferret out the truth behind such haste. It voiced, ‘the truth is that researchers, academic institutions, medical journals and the media all face powerful incentives to portray the latest research findings as more earthshaking than they actually are’. The authors spotlighted, under normal circumstances, numerous mechanisms exist to blunt some of the worst over-hyping and many sources of medical information do their best to be accurate in what they report.

It is possible that in the midst of a pandemic, the urgency of the moment may overwhelm these good intentions. The above paper also cautioned, ‘Bad science can be spread far and wide by normally credible sources.” However, the bottom-line is, the scientific research community, under no circumstances, be made to comply with the thoughts and beliefs of non-scientific, but powerful decision makers. It happened in the oldest democracy in the world, as it also happened in the largest democracy on the planet earth.

The above two instances are just illustrations to highlight an important point – without becoming judgmental. The discussion spotlights the perils of haste in the scientific decision-making processes, while combating Covid-19. As many experts believe, it could be counterproductive for non-scientific power sources to influence the robust medical value creators for a quick remedy. Mainly because, patients will continue to be at the receiving end for the net outcome, of such unproven, and scientifically fragile hypes.

By: Tapan J. Ray  

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

Quick implementation of the undiluted ‘Central Drug Authority (CDA)’ Bill is essential for emerging India

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Many industry experts after having evaluated the provisions of the original draft proposal for forming a Central Drugs Authority (CDA) in the country, commended and supported this laudable initiative of the Government. This Bill also known as, “The Drugs & Cosmetics (Amendment) Bill No.LVII of 2007 to amend the Drugs & Cosmetics Act, 1940” was introduced in the ‘Rajya Sabha’ on August 21 2007 and was thereafter referred to ‘The Parliamentary Standing Committee of Health and Family Welfare’ for review. The Committee also has submitted its recommendations to the Government since quite some time. However, the fact still remains that the proposed CDA Bill has not seen the light of the day, as yet.
Mashelkar Committee Recommendation:
It is high time to consider the recommendations of Dr. R.A. Mashelkar Committee on the subject and make amendments in Act to facilitate creation of a Central Drugs Authority (CDA) and introduce centralized licensing for manufacturing for sale, export and distribution of drugs.
Seven reasons for the dire need of the CDA in India:
I firmly believe that the formation of the ‘Central Drugs Authority (CDA)’ will provide the following benefits to the Industry and also the Government:
1. Achieving uniform interpretation of the provisions of the Drugs & Cosmetics Act & Rules
2. Standardizing procedures and systems for drug control across the country
3. Enabling coordinated nationwide action against spurious and substandard drugs
4. Upholding uniform quality standards with respect to exports to foreign countries from anywhere in India
5. Implementing uniform enforcement action for banned and irrational drugs
6. Creating a pan-Indian approach to drug control and administration
7. Evolving a single-window system for pharmaceutical manufacturing and research undertaken anywhere in the country.
Major countries have similar set up even within a federal system:
All major countries of the world have a strong federal drug control and administration system in place for the Pharmaceutical Industry. Like for example, despite strongly independent states within the federal structure of the U.S., the US – FDA is a unified and fully empowered federal government entity.
Similarly, coming together of many independent countries in Europe had led to the need for a pan-European drug control agency. This responsibility was vested on to the ‘European Medicine Agency (EMEA)’ with overriding pan-European authority and powers within the European Union (EU).
Thus, a single Central Authority that administers and regulates both pharmaceutical manufacturing and research is an absolute necessity in India’s bid to be a global hub for drug discovery.
The interim measure:
In my view, till CDA is formed, registration and marketing authorization for all new drugs and fixed-dose combinations should only be granted by Drugs Controller General of India (DCGI). I would emphasize, it is essential that a smooth transition takes place from the existing regulatory environment to the proposed CDA, carefully tightening all the loose knots in the process. All necessary infrastructures along with the required personnel must be in place, so that all permissions are granted to applicants within stipulated timeframe.
The watershed regulatory reform initiative should not get diluted:
The CDA Bill is widely considered as a watershed regulatory reform initiative in the pharmaceuticals space of India. This reform process, besides offering all other benefits as discussed above, would also be able  to update the legislation, considering significant advances the country has made since the last five decades, especially in the areas of clinical research, treatment methods, and sophisticated diagnostic and medical devices.
Conclusion:
It now appears, the Government could revive the CDA Bill and reintroduce it in the Parliament, sooner. It was to be introduced in its monsoon session. However, the plan did not fructify, as the Parliament could not function due to a logjam created by our politicians.
It is worth noting that the proposed centralize drug licensing mechanism was vehemently opposed by the state drug authorities and some section of the industry. The stated position of the opponents to the CDA Bill apprehends that the centralized structure will not be able to deliver, as the requisite infrastructure and manpower for the same are not in place, as yet.
This development bring out to the fore the lurking fear that the proposal to centralize drug licensing as a part of the proposed law, very unfortunately, may eventually get quite diluted because of vested interests.

By: Tapan J Ray

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

Pharma SMEs in India: a quick overview

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The spread of Pharma SMEs in India:
As per a recent study by Dun and Bradstreet, largest cluster of the Pharma SMEs is located in the western region of India contributing almost 55% of the total SMEs, based mostly in Maharashtra, Gujarat and Goa. This is followed by the Northern, Southern and Eastern regions with about 20% each located in the Northern and Southern regions and about 5% in the Eastern region of the country.

Mumbai, Ahmedabad, Hyderabad and Delhi are the key hubs of the Pharma SMEs. About half of the SMEs are Private Limited Companies with around 25% Public Limited, 15% Partnership and 10% proprietary firms.

Key activities:

The activities of the SMEs have been reported as follows:

• 75% companies are purely manufacturing companies with own facilities

• 13% companies are engaged in manufacturing as well as trading

• 10.5% of the companies are doing R&D work (clinical tests as well as contract research) along with manufacturing

• 1.5% of the companies were focused on only research & development

Around 50% of these companies are engaged in exports to various countries around the world, including USA and Europe.

The strengths:

High level of entrepreneurial zeal and low operational costs across various pharmaceutical business processes are the key strengths of pharma SMEs in India. However, the key question is whether such cost arbitrage is sustainable in the longer term.

Key challenges:

The key challenges encountered by the SMEs are as follows:

• Regulatory conformance to more rigid product quality norms to offer better quality of medicines to the patients

• Sustained investments towards technical upgradation to maintain competitive edge related to manufacturing cost

• Sales and Marketing activities are becoming more and more expensive, in terms of cost of skilled field staff together with their other consequential and modern day marketing tools/ practices in India.

It appears survival of those SMEs who operate only in highly competitive domestic market with manufacturing and/or marketing of low price formulations will indeed be increasingly challenging. This challenge will be even more with the SMEs who do not have enough wherewithals or get the support of the government to face squarely the rapidly changing business environment/demand and falter in choosing the right business models, as applicable to each one of them.

Incentives/facilities provided by the Government of India (GoI):

However, the Department of Pharmaceuticals, Ministry of Chemicals & Fertilizers of the GoI has been taking steps to support the SMEs through various incentives/facilities, as follows:

• Credit Linked Capital Subsidy Scheme (CLCSS) to SME pharma units, which will help them to upgrade their facilities as per the revised Schedule M

• List of products reserved for manufacturing by SMEs

• Identification of around 18 pharmaceutical SEZs, which will offer advantages like availability of developed infrastructure, market access and exports along with various tax incentives

GoI involvement in the R&D activities of Pharma SMEs:

As I indicated above, about 1.5% of the SMEs are now focused only on research & development. In ‘India Pharma Summit’ held on November 30, 2009, the Department of Pharmaceuticals of the Government of India announced as follows:

• The government is planning to set up a venture fund to promote R&D in the Pharmaceutical sector, especially for the SMEs

• This will be a close ended fund with a corpus of around Rs. 2000 crore

• The initiative will have active stakeholders both from the government as well as from the industry

• The broad outline of the scheme will emerge in the next two months and the fund will be operational in about three years

Moreover, incentives by way of extending the weighted deduction at the rate of 150% of the expenses on R&D for the next five years and duty exemption for imports of specified machinery used for R&D purpose will help the sector to augment its R&D capabilities.

Areas the Pharma SMEs should look at to strengthen themselves:

Increasing opportunities in the generic pharmaceutical market both domestic and exports will fuel the growth of SMEs having robust and focused business models and plans. Besides, rapidly emerging Contract Research and Manufacturing Services (CRAMS) market also throws open a lucrative outsourcing business space for the SMEs to cash on, leveraging their current cost arbitrage in collaboration with the large local and global pharmaceutical companies.

Conclusion:

The future of Pharma SMEs in India, in my view, is quite good, provided they can choose the right business model for growth. However, it is worth noting that the SMEs will now face much more and newer challenges related to the globalization process of the Indian economy and the markets, together with regulatory and social needs for improved quality of medicines and conformance to more stringent environmental and safety standards. Collaborative approach both with large domestic and global players will be of utmost importance and could be a win-win prescription for growth.

By Tapan Ray

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

Quick implementation of the UNDILUTED ‘Central Drug Authority (CDA)’ Bill is essential for emerging India

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Many industry experts after having carefully evaluated the provisions of the original draft of the proposal of forming a CDA in the country commended and supported this praiseworthy initiative of the Government. This Bill also known as, “The Drugs & Cosmetics (Amendment) Bill No.LVII of 2007 to amend the Drugs & Cosmetics Act, 1940” was introduced in the ‘Rajya Sabha’ on August 21 2007 and was thereafter referred to ‘The Parliamentary Standing Committee of Health and Family Welfare’ for review. The Committee also has submitted its recommendations to the Government since quite some time. However, the fact still remains that the proposed CDA Bill has not seen the light of the day, as yet.

Mashelkar Committee Recommendation:

It is high time to consider the recommendations of Dr. R. A. Mashelkar Committee on the subject and make amendments in the Act to facilitate the creation of a Central Drugs Authority (CDA) and introduce centralized licensing for the manufacture for sale, export or distribution of drugs.

Seven reasons for the dire need of the CDA in India:

I firmly believe that the formation of the ‘Central Drugs Authority (CDA)’ will provide the following seven significant benefits to the Industry and also to the Government:

 1.    Achieving uniform interpretation of the provisions of the Drugs &  Cosmetics Act & Rules

 2.    Standardizing procedures and systems for drug control across the country

3.    Enabling coordinated nationwide action against spurious and substandard drugs

4.    Upholding uniform quality standards with respect to exports to foreign countries from anywhere in India

 5.    Implementing uniform enforcement action in case of banned and irrational drugs

 6.    Creating a pan-Indian approach to drug control and administration

7.    Evolving a single-window system for pharmaceutical manufacturing and research undertaken anywhere in the country.

Major countries have similar set up even within a federal system:

All major countries of the world have a strong federal drug control and administration system in place for the Pharmaceutical Industry. Like for example, despite strongly independent states within the federal structure of the U.S., the US – FDA is a unified and fully empowered federal government entity. 

Similarly, the coming together of many independent countries in Europe has led to the need for a pan-European drug control agency and that responsibility has been vested on the ‘European Medicine Agency (EMEA)’ which has overriding pan-European powers, that is within the European Union (EU).

Thus, a single Central Authority that administers and regulates both pharmaceutical manufacturing and pharmaceutical research is an absolute necessity in India’s bid to be a global hub for drug discovery.

The interim measure:

In my view, till CDA is formed, registration and marketing authorization for all new drugs and fixed-dose combinations should only be granted by Drugs Controller General of India (DCGI).  I would like to emphasize, it is essential that there a smooth transition takes place from the existing regulatory environment to the proposed CDA, carefully tightening all the loose knots in the process. All necessary infrastructures along with the required personnel must be in place so that all permissions are granted to applicants within stipulated time frame.

The watershed regulatory reform initiative should not go waste:

Thus the CDA Bill is considered to be a watershed regulatory reform initiative in the pharmaceuticals space of India. This reform, besides all others as discussed above, would have updated the legislation considering the advances the country has made, especially, in the last five decades in clinical research, treatment methods, and sophisticated diagnostic and medical devices.

Conclusion:

It now appears that the Government could revive the CDA Bill and reintroduce in the Parliament. It was to be introduced in its monsoon session. However, the plan did not fructify because of various political reasons.

Centralize drug licensing has also been highly opposed by the state drug authorities and some section of the industry. The stated position of these opponents to the CDA Bill highlights that the proposed centralized structure will not be able to deliver as the requisite infrastructure for the same is not in place, as yet.

All these developments bring out the apprehension that the proposal to centralize drug licensing as part of the proposed law, very unfortunately, may get quite diluted because of vested interests.

By Tapan Ray

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

The stormy debate on wrongful grant of pharma product patents – a countdown of the news events, for a quick perspective.

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To give a quick perspective to this debate, I reckon, a countdown of five reported news events on the subject will be helpful. I start from February, 2009 and gradually go one year back, to February, 2008, to capture the key elements of this stormy debate. Finally, I move to ‘ground zero’ to explore the basic remedial measures to effectively address the issue.Event 5‘The Economic times’ (ET) dated February 24, 2009 reported an interesting news item titled, “Dichotomy between patent law and practice”. The timing of this article, with its various quotes, highlighting the following points, evokes interest:

1.“Indian patent authorities are virtually not following the spirit of the Sections 3(d) and 3(e)”.

2.“A large number of patents granted in India since 2005 pertain to products first patented in 1970s, 1980s, and 1990s, most of which were launched in Indian markets long before 2005, the year of introduction of product patenting in the country”.

3.“The patent applicants are not making adequate disclosures, making it difficult for potential challengers to file post-grant objections which the law provides for. Since the International Non-proprietary Name (INN) is not of the drug is often not given along with the Title of the Patent, it is cumbersome for anyone to trace the patent to the original PCT (Patent Cooperation Treaty) application and have an idea about how new it is”.

4.“Many law firms refuse to take briefs from Indian companies, because their multinational clients do not permit them to do so! The result— post-grant objection facility is not effectively used by Indian companies.”

Why are these observations interesting?

These observations are interesting because for point number 1 to 3, as stated above, following three recourses are available to all:

1. After publication of the patent applied for, in the patent journal, one can file a pre-grant opposition.

2. Assuming that someone has missed this opportunity, the provision for filing post grant opposition will still be there.

3. Assuming that both the opportunities have been missed due to some reasons and one could not understand the details of the patent applied for, during the patent granting process, the opportunity of going to a Court of law with a request to make such patents (which have violated section 3.d) invalid, will still exist.

It is indeed very difficult to understand why such measures are not being taken by the aggrieved parties, as specified in the law.

Point number four is even more difficult to understand. When lawyers are available to the domestic companies to defend alleged patent infringement, why then lawyers will not be available to them to take such objections to a court of law?

Event 4

Mint dated October 7, 2008 in its article titled; “Cozy deals and conflicting interest mark patent granting process” reported the following:

“There are even local and multinational corporates who ‘seek’ help of examiners and controllers to get their applications drafted, thereby ensuring a grant for a price”.

Event 3

‘The Economic Times’ dated July 1, 2008 reported in its article titled, “Cipla gets patent for Nexium, Fosamax modified versions” that Mumbai Patent office granted these two patents to Cipla in April, 2008 for new forms of two well known blockbuster drugs, Esomeprazole (Nexium of Astra Zeneca) and Alendronate (Fosamax of Merck). This news came as a big surprise because Cipla is well known for its continuous accusation to innovator companies for trying to extend ‘monopoly’ period by ever-greening patent through similar means. The report, therefore, raised a very valid question, whether Cipla has ‘walked the talk’ in India? It will be interesting to know on what basis Cipla managed to overcome the ‘efficacy’ barriers under section 3(d).

On this ET report, well known IPR expert Shamnad Basheer wrote the following in his blog dated July 6, 2008:

“Reading the ET piece, Nathan Evans of Finnegan Henderson, who’s a very astute commentator on the Indian patent scene and has written a couple of articles in this regard posed this question to me:

“This makes me wonder if the patent office in India will apply the laws less strictly to Indian pharmas than MNCs (kind of like they apply the patent laws more strictly for essential medicines)”

Shamnad Basheer concluded his comment on this subject with the following observations:

“How ought section 3(d) to be interpreted when our very own generic manufacturers are applying for supposedly “incremental” inventions?”

Event 2

According to Federation of Indian Chambers of Commerce (FICCI) report dated March 7, 2008, FICCI and the Department of Industrial Policy and Promotion (DIPP), Ministry of Commerce and Industry have joined hands to set up a working group to improve Intellectual Property regime in India.
It will be interesting to know the view of this joint working group between the Government and the Industries, in this matter. I have not read anywhere any comments of this important working group on such matter, so far.

Event 1

‘Thomson and Reuters patent focus report’ dated February, 2009 observed absence of clear guidelines (Manual of Patent Practice and Procedure) about some of the complex provisions of patent law, particularly section 3(d). The report indicated that there should be clarity on what would qualify as “enhanced efficacy” under section 3(d) so that it can help the patent examiners to clearly make out which patent applications would fall under section 3(d).

Ground Zero:

Let us now try to ponder, realize and fathom the core issue of this problem, which lies at the ‘Ground Zero’. Thus far we have been reading constant allegations about the functioning of Indian Patent Offices and even on their integrity and honesty.

In absence of a well drafted, long overdue, Patent Manual, all concerned, including patent examiners will have their own ways of looking into “enhanced efficacy”. In such a situation, I shall not be surprised if the Patent Examiners suffer from the dilemma as to what exactly will constitute “enhanced efficacy”.

Protracted debate with the stakeholders on the ‘draft patent manual’ appears to be over now. The last stakeholders’ meeting on this subject was concluded in Kolkata following Delhi, Mumbai and Bangalore, several months ago. However, the final Patent Manual is still not in place, which has been kept for public inspection since 2005.

To address this stormy debate, in my view, we need to:

1. Push for expeditious release and implementation of the Patent Manual (Manual of Patent Practice
and Procedure).

2. Let FICCI – DIPP working group work more effectively and cohesively for better functioning of the
new IPR (Intellectual Property Rights) regime.

3. Let ‘capacity building’ exercise at the Indian Patent office (IPO) continue with greater speed.

Mere accusation and constant bashing of the IPOs, as we now see around, may not yield much result. After having taken the above measures, if similar dissatisfaction in any quarter still remains, let law take its own course. Despite great apprehensions by some, as quoted above under point 1, never mind, enough lawyers will be available to fight such cases.

By Tapan Ray

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

R&D and Protection of IPR related to Pharma sector, are now the responsibilities of the Department of Pharmaceuticals (DoP) – a quick look at the initiatives taken by the department.

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On July 2, 2008, the Cabinet Secretariat of the Government of India notified creation of a new department to be known as the Department of Pharmaceuticals (DoP) under the Ministry of Chemicals and Fertilisers with an objective to have a sharper focus on the Pharmaceuticals Industry of India. In that notification besides other important areas, Research and Development (R&D) and protection of Intellectual Property Rights (IPR) related to the Pharmaceutical sector, were brought under the newly created department.In this discussion let us try to have a look at the progress in both the R&D and IPRareas, separately.After creation of the new department, the Minister of Chemicals and Fertilisers Shri Ram Vilas Paswan, announced a proposed allocation of Rs. 10,000 crores (around US$ 2 billion), together with necessary regulatory reforms, towards annual Pharmaceutical R&D funding by the DoP.

The Government expects that such initiatives will help bringing in transformation of the Indian Pharmaceutical Industry from brilliant and highly successful ‘imitators’ to world class ‘innovators’ of path breaking medicines. Discovery of such medicines in India is also expected to help the Government significantly, to improve access to affordable innovative modern medicines to the common man of the country. All these are no doubt, very laudable initiatives by the DoP, with a very capable, effective and a ‘can do’ leader at its helm.

The DoP plans to bring in significant changes in the clinical trial facilities available within the country. Currently even very basic clinical trials on ‘dogs’ cannot be undertaken because of protests from the activists related to ‘prevention of cruelty on animals’. Such reform measures, I am sure, will be sincerely welcomed by many.

It is interesting to note that the DoP is also planning to extend Regulatory Data Protection (RDP) to innovators. It has been reported that the invaluable data generated by the innovators towards development of the New Molecular Entity (NME) will, in near future, be protected from ‘piracy’ during 20 year patent life of the product. However, the DoP cautions that attempt to ‘evergreen patent’ through data protection, beyond the patent life of a product will not be permitted.

The argument of the innovators on this issue is that Product Patent and Clinical Data are two different types of intellectual properties and should not be considered as one and the same. While patent protection is extended for discovery of the molecule, data protection is for the immense and expensive clinical data that the innovators share with the Government for regulatory approval of the patented molecule, within the country. The argument that such valuable data generated by the innovators is an intellectual property (IP), lies in the premise that if the innovator would not have been required to part with the data with the regulatory authorities, such data would have been regarded as a ‘trade secret’, which is an IP. Therefore, the innovators argue that for sharing this IP with the Government, specific period of data protection to be extended to them, which should be unrelated to the life of the patent.

Thus far, we see that DoP has taken some very important and admirable initiatives to encourage R&D within the country. However, while looking at another important area of its responsibility i.e. protection of IPR within the Pharmaceutical sector, nothing has been announced by the department, as yet.

Encouraging R&D without effective protection of IPR, points towards an incomplete agenda to effectively address pharmaceutical product innovation related issues by the department. I sincerely hope that the DoP will soon announce its policy initiatives towards IPR protection to further encourage the innovators, both within and outside the country.

The DoP has taken some significant steps to address various important issues of the pharmaceutical industry under its terms of reference, within a very short period. I look forward to knowing from the DoP the detail initiatives in each of its nine functions and responsibilities, as announced in the notification of the cabinet secretariat on July 2, 2008.

By Tapan Ray

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.