India is the largest provider of generic drugs globally. The Indian pharmaceutical-sector industry supplies over 50 per cent of global demand for various vaccines, 40 per cent of generic demand in the US and 25 per cent of all medicine in the UK. India is the largest contributor in UNESC with over 50-60% share
India’s potential to be the “pharmacy of the world”
- Potential of Pharma sector: The Indian pharmaceutical industry, valued at $41 billion, is expected to grow to $65 billion by 2024 and $120-130 billion by 2030, noted the new Economic survey.
- Rise in exports: During April-October 2020, India’s pharmaceutical exports of $ 11.1 billion witnessed a growth of 18 percent against $ 9.4 billion in the year-ago period.
- Positive growth: Drug formulations, biologicals have consistently registered positive growth and the highest increase in absolute terms in recent months.
- This led to a rise in its share to 7.1 percent in April-November 2020 from 5 percent in April-November 2019, making it the second-largest exported commodity among the top 10 export commodities.
- Significant advantage: The availability of a significant raw material base and skilled workforce have enabled India to emerge as an international manufacturing hub for generic medicines.
- Further, India is the only country with the largest number of USFDA compliant pharma plants (more than 262 including APIs) outside of the US.
- Capacity: The COVID-19 pandemic has shown that India can not only innovate but also rapidly distribute time-critical drugs to every part of the globe that needs it.
- Global leader: Presently, over 80% of the antiretroviral drugs used globally to combat AIDS (Acquired Immune Deficiency Syndrome) are supplied by Indian pharmaceutical firms.
- Overdependence: Indian pharma industries import about 80% of Active Pharmaceutical Ingredients(API) from China. The API forms the base of drugs. With trade-wars at global levels and wavering bilateral relations, there is a looming threat which can stall the Indian pharma industries. In FY19, Indian pharma companies imported bulk drugs and intermediates worth $2.4 million from China.
- Compliance issues and good manufacturing practices: Diversifying the global market has been a problem with countries China and USA imposing Sanitary and Phyto-Sanitary(SPS) barriers of WTO against generic drugs. The selective targeting by US Food and Drug Administration and Chinese Drug regulators are a problem still.
- Drug Price Control Order: The companies sight that the reforms of the Government for the essential medicines has caused them to lower the price of drugs. This has been done by the Government for the betterment of the public.
- Stronger IP regulations: IP regulation has always been a thorn in the skin for the companies, especially the foreign companies. The companies strongly feel that the rules have to be amended and the so-called victim of the lax regulations have been the foreign entrants.
- Because of fewer costs associated with generic medicines, multiple applications for generic drugs are often approved to market a single product; this creates competition in the marketplace globally, typically resulting in lower prices. Pharma sector in India is also facing steep headwinds on account of this.
- There is a lack of proper assessment of the performance of the pharmaceutical industry and its efficiency and productivity and due to this many plants have not survived.
- Unregulated online pharmacies or e-pharmacies emerging in India have been a major concern for authorized setups.
- There has been a significant drop in the flow of prescriptions as the Indian pharmaceutical industry has been witnessing a decline in the overall quality of its medical representatives (MRs). This is mainly on account of lack of training and support by the industry.
- In countries such as Russia, one requires to be a medical graduate to be a pharma sales representative. In the European Union, one needs to pass stringent examinations to become an MR. Once they qualify, they need to renew their certification every three years. But in India, even non-graduates are performing as MRs without proper guidance.
The affordability of healthcare is an issue of concern even in India, and people here would welcome some clarity on the principles of fair pricing vis-à-vis medical products. It is important that the accused companies are given a good hearing. The Government of India has taken up a number of initiatives to create an ecosystem that fosters manufacturing in pharma industries