DTAB suggests one-time licensing for drugs
The Drugs Technical Advisory Board (DTAB) recently recommended one-time licensing for manufacture and sales of drugs.
If the recommendation is approved it will change present of the renewal of licences for each formulation which rests with state regulators and takes around three years. However, the new rule will have a condition that there be at least one annual inspection and in cases where risk is high.
- Separate rules for manufacturing, import, sale and distribution of cosmetics. It has suggested the European Union’s model.
- Making of influenza drugs Oseltamivir and Zanamavir must be made available widely at all pharmacies, by putting it in the Schedule H1 list.
- These two drugs at present have been treated as Schedule X drugs and available at select pharmacies. Retain the four-year approval threshold for ‘new drugs’.
- If the definition of a new drug is extended to 10 years, then innovation will take a back seat and wanting the four-year period to be retained.
If these recommendations are approved it will help in ‘ease of doing business’ and give fillip to domestic pharmaceutical sector under Union Government’s ‘Make in India’ initiative at a time when the country is slipping in the competitiveness index. It will also give a boost to pharmaceutical industry and give comfort to our customers.
Drugs Technical Advisory Board (DTAB): It is the highest statutory decision-making body under the Union Health ministry on technical matters. It is constituted as per the Drugs and Cosmetics Act, 1940.