Drugs licences to go costlier with this proposed government rule

If a new proposal by the Ministry of Health and Family Welfare gets accepted, drug makers would be required to shell out significantly higher fees for licences, registration, and manufacturing of drugs.

Multi-fold fee hike for product registrations, manufacturing and product licences and clinical trials have been proposed by the Ministry of Health and Family Welfare. The Central government thinks that this is the right time to change the rules, keeping in mind the international rates of drug licensing. However, the Drugs Technical Advisory Board, which was set up to advice the Central Government on important policy decisions, has not been consulted as of now.

As per provisions, the consultations would be done within six months from date of publication of rules.

Talking of the proposal, it asks for more than six-fold increase in the site registrations, from $1,500 to $10,000. Product registrations, on the other hand, would jump to $5,000 from $1,000.

For local manufacturing and loan licence, the fees will jump more than eight-fold to Rs 50,000 from Rs 6,000 while for site inspections, charges will increase 10-fold to Rs 15,000. There would be a tenfold increase in the fees for a licence to import drugs, which would jump to Rs 10,000 from Rs 1,000. Regarding the registration of a new drug, fees proposed will increase five-fold, from Rs 50,000 to Rs 250,000.

With these new changes, however, the “Make In India” initiative is set to suffer, at least in the pharmaceutical industry.

Image source