Health NGOs Global AIDS Alliance and Stop HIV/AIDS in India Initiative have expressed their concerns over the government plans to amend Drugs and Cosmetics Act to prevent the use of innovator's data for drug regulatory approval.
In a letter to the Prime Minister, the NGOs complained that the implementation of data exclusivity provisions as an amendment to the Drug and Cosmetic Act would seriously affect India's ability to provide drugs to millions of people around the world living with diseases such as HIV/AIDS, hypertension, diabetes, asthma, and many more.
"Data exclusivity provisions, if added to the Drugs and Cosmetic Act will prevent generic companies from using data on existing drugs to gain regulatory approval for generic versions. Generic companies would be forced to repeat time-consuming and expensive studies to receive regulatory approval. Essential medications would be prohibitively expensive without the competition from generic companies and generic drugs would take years to bring to market under data exclusivity laws. Repeating clinical trials would force drug companies to perform unethical studies that withhold medicines known to be effective from the control group. The people of India and the developing world would be denied access to the newest treatments available to those who can afford brand name drugs," they stated.
The NGOs expressed fear that without Indian generic drugs, millions of people in developing countries will die as a result of lack of access to affordable medicines.
Stating that the Ministry of Commerce has already publicly stated its opposition to the implementation of data exclusivity provisions, the NGOs hoped the Ministry of Health and Family Welfare and the Ministry of Chemicals and Fertilizers to follow suit and oppose a data exclusivity amendment to the Drugs and Cosmetic Act.
The appeal has also gone to Ramvilas Paswan, Minister of Chemicals and Fertilizers, Dr. Anbumani Ramadoss, Minister of Health and Family Welfare, Kamal Nath, Minister of Commerce and Industry and Jairam Ramesh, Minister of State for Commerce.