[1] India is the world's largest provider of generic medicines by volume, with a 20% share of total global pharmaceutical exports.
[2] Indian pharmaceutical products are exported to various regulated markets including the US, UK, European Union and Canada.
States have started to vie with one another for biotech business, and they are offering such goodies as exemption from VAT and other fees, financial assistance with patents and subsidies on everything ranging from investment to land to utilities.
[14] The Government started to encourage the growth of drug manufacturing by Indian companies in the early 1960s, and with the Patents Act in 1970.
[15] The government has addressed the problem of educated but unqualified candidates in its Draft National Biotech Development Strategy.
This plan included a proposal to create a National Task Force that will work with the biotech industry to revise the curriculum for undergraduate and graduate study in life sciences and biotechnology.
The government's strategy also stated intentions to increase the number of PhD Fellowships awarded by the Department of Biotechnology to 200 per year.
Government grants are difficult to secure, and due to the expensive and uncertain nature of biotech research, venture capitalists are reluctant to invest in firms that have not yet developed a commercially viable product.
[16] Government of India has launched a Production Linked Incentive (PLI) Scheme for Pharmaceuticals with provision for disbursal of US$2 billion or ₹15,000 crore government incentives, which will run from 2020–21 to 2028–29, to reduce import dependence, benefit domestic manufacturers, boost product diversification and innovation for development of complex and high-tech products especially in in vitro diagnostic devices and emerging technologies especially in cell based or gene therapy, employment generation and production of wide range of lower cost affordable medicines for consumers with the aim to achieve incremental sales of US$4 billion or INR 29,400 crore and incremental exports of US$2.7 billion or INR 19,600 crore between 2022–23 to 2027–28.
[18] Separately, FDI up to 100% is permitted for the manufacturing of medical devices for both greenfield and brownfield projects without the approval of the DoP.
Unlike in other countries, the difference between biotechnology and pharmaceuticals remains fairly defined in India, with biotech a much smaller part of the economy.
Pharmaceutical companies in both countries see growth potential in biotechnology and have either invested in existing start-ups or ventured into the field themselves.
Although the initial investment is huge, companies are lured by the promise of hefty profit margins and thus a legitimate competitor in the global industry.
India and other developing countries were provided an extra ten years to comply fully with the conditions mandated by TRIPS.
India succeeded in including a crucial clause to the agreement in the form of the right to grant compulsory licenses (CLs) to others to manufacture drugs in cases where the government felt that the patent holder was not serving the public health interest.
In 2005, a provision was added to the new legislation as section 3(d) which stipulated that a medicine could not be patented if it did not result in "the enhancement of the known efficacy of that substance".
The legislation took effect on the deadline set by the WTO's Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement, which mandated patent protection on both products and processes for a period of 20 years.
[27] In December 2005, the TRIPS pact was amended to incorporate specific safeguards to ensure that the public health concerns of affordability and accessibility for a large section of people in developing countries was not compromised.
Meanwhile, Indian firms have chosen to take their existing product portfolios and target semi-urban and rural populations.
[32] Cipla, another large Indian pharmaceutical company, is noted for its pioneering role in manufacturing and exporting low-cost generic HIV/AIDS drugs to developing countries.
[34] As of 2021, India's APIs market is worth $11.8 billion and is forecasted to grow at a compound annual growth rate of 12.24% until 2027.
[40][41] Most of India's CRAMS companies and contract manufacturing organizations (CMO) operate in the small molecules segment.
[42] Piramal Pharma, through its investment in Yapan Bio offers CDMO services for biologics which include vaccines, gene therapies, and monoclonal antibodies.
[53] SII and MassBiologics, part of the University of Massachusetts Chan Medical School, developed Rabishield, a first of its kind rabies human monoclonal antibody.
[54] Bharat Biotech, in collobartion with the Indian Council of Medical Research (ICMR) - National Institute of Virology (NIV), developed Covaxin, India's first COVID-19 vaccine.
[66] On 5 October 2022, the World Health Organization issued a medical product alert that was linked to acute kidney injuries, and the deaths of 69 children in the Republic of the Gambia.
[67] The medical alert was issued as the World Health Organization claimed that after sampling batches and conducting laboratory analysis[68] its investigators had found that these products had "unacceptable levels of diethylene glycol.
This decision was then appealed by Gilead Sciences, and subsequently the Indian Patent Office in New Delhi approved the drug.