The drugs technical advisory board recently recommended one-time licensing for manufacture and sales of drugs, with a rider that there be at least one annual inspection and in cases where risk is high. At present, the renewal of licences for each formulation rests with state regulators and is around three years.
- It will help in ‘ease of doing business’ and the government’s ‘Make in India’ initiative at a time when the country is slipping in the competitiveness index. It will give a boost to industry and give comfort to our customers.
- The board has also asked for separate rules for manufacturing, import, sale and distribution of cosmetics. It has suggested the European Union’s model.
- It has proposed making influenza drugs Oseltamivir and Zanamavir available widely at all pharmacies, by putting it in the Schedule H1 list.
- The two drugs have been treated as Schedule X drugs, available at select pharmacies.
- Another recommendation is to retain the four-year approval threshold for ‘new drugs’.
- The domestic industry felt if the definition of a new drug is extended to 10 years, innovation will take a back seat and wanting the four-year period to be retained.
The Drug Controller General of India (DCGI) regulates pharmaceutical and medical devices, under the gamut of Ministry of Health and Family Welfare.