India is an important player in the global market and is rapidly growing its presence in the global pharmaceutical industries. It is the largest provider of generic medicines globally and possesses 20% of the total global market share in terms of supply by volume and also supplies 62% of worldwide demand for vaccines. India holds 3rd position in the global market for production by volume and 14th by value.
India is the only country with the largest number of US-FDA compliant Pharma plants (more than 262 including APIs) outside of the USA. India has more than 2000 WHO-GMP approved Pharma Plants, 253 European Directorate of Quality Medicines (EDQM) approved plants with modern state-of-the-art Technology.
About Drugs License
India is the source of 60,000 generic drugs brands across 60 therapeutic categories and manufactures more than 500 different Active Pharmaceutical Ingredients (APIs). The API industry is ranked third largest in the world contributing 57% of APIs to prequalified list of the WHO.
Drugs are needed for ensuring the good health of a country. Drugs are totally different from other commodities and because of that, the Government has laid down strict laws. The Central Drugs Standard Control Organisation (CDSCO) under Director-General of Health Services, Ministry of Health and Family Welfare, Government of India, is the National Regulatory Authority (NRA) of India. The regulations governing the manufacture & sale of drugs are given in the Drugs and Cosmetics Act, 1945 and Rules framed thereunder.
Drugs are different from other products a sthese have the lifesaving capacity, so it is very important for the Government to regulate the manufacturing and sale of the drugs.
To protect consumers
To protect public health
To protect from malpractices