Having expressed grief and concern repeatedly, ad nauseam, in many forums, including in these columns, it is compelling to express one’s cognitive dissonance as a seasoned observer of pharma industry for last nearly 50 years. Further, having been associated from the days of the birth of the modern Indian formulation and bulk drug industry, it is my bounden duty to appreciate and acknowledge the “handholding” and the “friend, philosopher and guide” attitude of the Government of India, in the early days of the sprouting of the Indian pharmaceutical industry during early 70’s, extending to the 80’s and thereafter.
The pharma entrepreneurs were fortunate to have had the company of the nationalist leaders, including ministers and parliamentarians during finalisation of major milestone policy documents such as, Hathi Committee Report 1975, Drug Policy 1978 and the landmark enactment of the Indian Patents Act, 1970 restricting patents in pharma only to processes, brainstorming in formal as well as informal forums. Even 1987 Drug Policy was deliberated, drafted and implemented, keeping in mind the need for healthy growth of the Indian pharmaceutical industry. The success of these initiatives by the Government of India under the leadership of pharma industry stalwarts and nationally committed bureaucrats, alerted and frightened the International competition, so much so, they went for the Uruguay round-based introduction of IPR (Intellectual Property Rights) into the GATT to bridle and stifle the Indian pharma growth.
The bulk drug /API industry in India, which was born in early 70’s, post the 1970 Patent Act Amendments, grew up along with the giant leader, IDPL (Indian Drugs and Pharmaceuticals Limited). The early initiatives for encouraging bulk drug production, such as the ratio parameters and incentives on bulk production for captive consumption helped the growth of bulk drug industry in India. However the very bulk drug /API industry, so lovingly nurtured by the government in the early years , was virtually killed by the subsequent governments by introducing stringent, non-viable price controls on API industry combined with unhelpful attitude of the pollution control boards and other disincentives. While every industry has some black sheep, the entire industry was penalized and punished for the default by one or the other. The flagship institutions of India, such as Haffkine institute, Mumbai (who invented vaccine for Kala-azar), HAL (Hindustan Antibiotics Limited) Pune (who invented Hamycin) and IDPL (Indian Drugs and Pharmaceuticals Limited) who was successfully catering to more than 50% of bulk drugs /API requirements of Indian pharma industry, were brutally and systematically exploited and destroyed due to negative interventions and extreme bureaucratic antipathy of the 90’s and thereafter. Domestic and personal servants were on the rolls of IDPL. Every time the Minister went on the stage, price reduction of IDPL products used to be announced to gain popularity. A few factors adversely affected the growth of the pharmaceutical industries post 90’s. Prominent among them were the License Raj era, which created mistrust and lack of transparency and co-ordination. The pharma industry and the government started moving in different directions. By the mid 90’s, increasing influence of the leftist NGO’s (which has peaked in recent times) was another factor for collapse of India’s leadership position in bulk drug /API industries as well as for increasing controls on the Indian pharmaceutical industries.
The NPPA (National Pharmaceutical Pricing Authority), set up as a dedicated Price Regulator in 1997 to replace BICP has been going hammer and tongs increasingly against the Indian pharmaceutical industry, directly as well as under the pressure from judiciary, both succumbing to the influence of overzealous NGOs. While in 1970, Patent Law Amendments of India helped the growth of pharmaceutical industry by leaps and bounds, the 1995 WTO and TRIPS regime brought in new regime rules, product patent restrictions and challenges on the Indian pharmaceutical industry, compelling them to go more and more for innovation, drug discoveries and increased expenditure on pharmaceutical development and research.
The Indian pharma industry adapted to the WTO/TRIPS regime and rules proactively and attempted to adapt to the need for innovative research. The change of gear from, positive to negative attitudes in the Health and Pharmaceuticals ministries and departments thereof, such as NPPA, CDCSO and others forced the Indian pharma industry to divert attention on defensive strategies and firefighting. Industry leaders such as Dr. Parvinder Singh of Ranbaxy and Dr. Anji Reddy of Dr. Reddy’s Labs who were the early pioneers of drug research in India virtually and sadly saw their dreams crashing down due to unhelpful attitude and lack of creative support from the Government. Dr.Yusuf Hamied of CIPLA who received global accolades and recognition for his and CIPLA’s contribution to Global Healthcare and affordable access projects was nearly neglected in India and never consulted on Indian Drug Policies and visionary initiatives.
The Pharma Vision 2000 which was initiated in the late 70’s and early 80’s under IDMA was headed by Dr.Yusuf Hameid. This private initiative helped to provide a road map for growth of pharma industries between the 80’s and 2000. Over the years, the pharma industries and the government have been moving apart to the detriment of the Indian patients. The true Nationalists such as Dr.Yusuf Hamied have become disillusioned today. Dr. Hamied says “Time has now come to say goodbye to India” (Business Standard February 11, 2013), for obvious reasons. It will be sad if the flagship company, CIPLA, gets adversely impacted due to the apathy and antipathy of the Health Managers in the Government of India.
The Indian pharma industry is going through the most challenging times today, in a span of last 50 years. The atmosphere of the Indian pharma industry has never been so convoluted. While there is a global mission and strategy of the Indian Government at the top, it has not only not percolated to the respective ministries and departments, but also these very same departments are indulging in over-regulating and over-controlling the otherwise already heavily regulated pharmaceutical industries. The over indulgence of the judiciary partially prompted in the NGO’s and partially pushed forward in the over-enthusiastic bureaucracy, has also complicated the scenario.
It is in this context that the announcement that “Modi government planning a major overhaul of country’s drug policy”, dawns as a light at the end of the tunnel or silver lining in the other-ways heavily clouded Indian pharma industry-skies. While India had all along had and continues to have a strong foundation to make it big in global pharma, it is unfair to blame the Government only. Pharma industry is equally responsible for the predicament we are in today. Over the years the Indian pharma industries became heavily fragmented and divided in almost all issues on every sensitive areas, whether it is pricing, quality, regulatory, industrial pollution, clinical trials, ethical responsibilities and good governance and many others.
Post 2005, the product patent regime has come to stay. Post 2015, it is time for product patent related litigations to be concluded and settled out of court. Compared to early years, the voluntary licensing is becoming the order of the day. More and more Indian companies who have the competence, quality standards and GMP, are receiving voluntary licenses for patented products. The industry has been exploited for many years and many ways under the divide and rule policy of the erstwhile governments. It is time for the Indian pharma industry and the government to come together and help resolve the challenges of our time. These are times of “Make in India” and not “Quit India” as (Dr. Hamied was quoted earlier).
At toll booths, even Kirana stores and others, especially in rural areas, toffees are given as change when the balance to be returned in less than 5 rupees. It is astonishing that in India a patient can still buy a strip of 14 tablets of 75mg Aspirin at Rs. 4.12 manufactured in stringent quality control assured, good manufacturing of GMP environs.
The thermolabile product (Aspirin) manufactured under moisture protected environment, stabilized and enteric coated and packed into aluminium foils being sold at Rs. 4.12 (US$ 0.05) is only accessible in India and nowhere else. Is it not a miracle? It will not be surprising if the NPPA still targets for reducing the price further from Rs. 4.12 for a strip of 14 tablets. It has been so distressing to hear from the NGOs who are close to the Health Ministry, in public platforms stating that drug prices are the highest in India supported by concocted statistics in any deliberations.
In Health Ministry or DOP, the industry views are less respected and cared for. While there have been many public statements that (license raj is coming to an end) and that these are times with enhanced “Ease of Doing Business”, the pharma industry in India have been more and more in the receiving end. From time to time there have been many attempts from well-meaning bureaucrats to help the growth of the Indian pharma industry, but such efforts have miserably failed due to the overall negatives in the system. Organisations such as IDMA and Pharmexcil have been singing paeans proclaiming success of the Indian pharma industry, so much so, it is a possibility, that the overzealous international competition may be pursuing through influential but invisible forces, to meddle and disturb the Indian pharma waters. The once-flourishing Indian bulk drug/API industry has heavily been substituted by and have become increasingly dependent on Chinese raw materials.
The DOP had declared 2015 as the year of the API industry (bulk drug). However, for reasons best known to the government, 2015 passed off uneventfully. India continues to be heavily dependent on China for building blocks (to almost 90%) and crude intermediates and crude bulk drugs (to the extent 80-85%). There have hardly been any effort in the field of API, due to guaranteed and assured negative returns as well as antipathy and negative attitude of the government. While large scale manufacturers, heavy industrial activity and wealth creation were appreciated in the early years after Indian independence, in recent times industrial expansion, expectation and achievements of exemplary ROI (return on investment) and value/health creation are looked down upon, surprisingly as anti-national activities.
Unless the Global Vision and lofty Mission and Nationally positive attitude to Indian pharma/ bio industries trickles down to the operational branches and by-lanes of pharma governance, the Indian pharma industries may have to increasingly opt for greener pastures to service the stakeholders and pursue the innovate dreams of the Indian pharma entrepreneurs which is already happening. Let us hope that more and more Indian pharma CEOs don’t follow the route of Dr.Yusuf Hamied who said that it is time to quit (As reported in Business Standard).
In the 70’s and 80’s or even thereafter one could express their free and frank opinions without fear in public interest, however today the times have changed. Very few frank opinions are expressed for fear of official retribution and retaliation. The views expressed here are strictly personal from nearly 50 years exposure to Indian pharma industry and may not be construed as emanating from or representing any organization or institution.
If the Nation benefits from a soul searching and attitudinal change of actions and directions, why should it not be considered as a serious option? While the Government of India is concentrating on “Make in India” with “Ease Of Doing Business,” most Indian National Pharmaceutical companies are compelled to set up not only pharma research centres overseas in Europe and USA, but are also increasingly setting up pharma manufacturing facilities overseas. Wealth and Health creation is welcomed and appreciated elsewhere.
(The author is CEO, Gopakumar Nair Associates)