Regulations for pharma ingredients in India – Too much hope from a complex market in 2019

Active Pharmaceutical Ingredient production in India, though a rapidly expanding industry, still faces a lot of competition form the international market. Dr Siddharth Dutta, Senior Healthcare Adviser,  finds how despite taking measures, the API manufacturing industry is struggling because of the loopholes in the policy framework

The Drugs and Cosmetics Act of 1940, which was framed in British India some 79-80 years ago, became the basis of import, distribution, manufacture and sales of drugs in India and still continues to be so. Later, the Drug and Cosmetics Rule of 1945 and the 1940 Act were clubbed to list down detailed manufacturing requirements and to check the production of spurious and low quality pharmaceutical ingredients. Since then, various revisions and amendments have been considered, implemented and they led to the present day state of regulations. Major among these are Pharmacy Act 1948, The Drugs & Magic Remedies (Objectionable Advertisements) Act, 1954, Indian Patent Act 1970, Trade Marks act 1999, Drugs Price Control Order, 1995 (DPCO), Uniform Code for Pharmaceutical Marketing Practices (UCPMP) and Research and Development Cess Act, 1986. These have, directly or indirectly, impacted this sector and are largely responsible for the growth or hurdles for various manufacturers in India until 2019.

Presently, drug regulations are segmented into two bodies i.e. the Central Drug Authorities and the State Drug Regulatory Authorities. The Central Drugs Standard Control Organization (CDSCO) is the apex national drug regulatory authority for carrying out the responsibilities allotted to the Central Government in accordance with the Drugs and Cosmetics Act, while the State DRA controls the state level affairs. Besides CDSCO and State regulatory agencies, others are The Drug Controller General of India (DCGI) and National Pharmaceuticals Pricing Authority (NPPA – 1995); both are equally expected to support this industry.

Are expectations and hopes too high for this market?
If one looks at the clinical trials industry in India, it is on a decline due to various reasons like regulatory delays and compensation issues when compared to markets such as China, Japan and Korea in APAC and the US in West. While many claim that the Active Pharmaceutical Ingredient (API) manufacturing industry is expanding and growing, I have some concerns. Yes, growth is being reported in pockets – look at Gujarat and Maharashtra – but what about other factors?
Currently, over 60 per cent of APIs are sourced from other nations. For some specific APIs, the dependence is over 80-90 per cent, according to the Department of Pharmaceuticals. There are serious raw material supply disruptions and pricing volatility in the Indian market which creates confusion in the market. While the hype and hope continues, our dependency on foreign API also continues.

In 2018, the Ministry of Chemicals and Fertilizers, along with some other ministries, had set up plans to draw up a road map for increasing API production in India. The ministry feels that this is definitely going to reduce our dependency on the markets such as China, Japan, the USA and others. So where is the problem?

The problem is that this exercise has been going on for years and years and we just conveniently ignore the past. Considering the political scenario in India, every time a new government comes in power, they restart the entire process with their own terms and conditions. For instance, the Congress-led government had done something very similar under Dr. V.M. Katoch, Director General of Indian Council of Medical Research in 2013. Back then, the committee had submitted its recommendations in 2015. Then, with the change of government, came new ideas and energy which led to formation of another committee in 2018 to review something similar. It’s up to you now, how you want to interpret this new development in 2019, especially now, when we are about to go for next round of elections.

Indian pharma market is one of the fastest growing markets after China. In terms of demand in the market, we are prominent, but when it comes to manufacturing of API and generics, we are somehow struggling in terms of getting approvals, maintaining international quality, GMP and more. The policies and laws are very much there, but so are the the gaps in this complex market. No matter which government comes next, no matter which new committee is formed to review the state of affairs, things do not seem to be changing in 2019-2020.

It’s a long road ahead. I am reminded of the famous quote by Robert Frost, “The woods are lovely, dark and deep…miles to go before I sleep”.