Norms for R&D in medicine simplified

Manufacturing of drugs derived from DNA technologies and those from specific cells or tissues will no longer require a compulsory industrial licence under the Industries (Development & Regulation) Act, 1951.

The Cabinet last week approved decision to withdraw the licensing requirement for both drug and pharmaceutical items.

Government officials told Business Standard that the department of industrial policy and promotion would soon issue a notification to this effect.

Both these items were earlier included in the list of industries requiring compulsory industrial licensing under the category of hazardous chemicals.

Officials said the decision was based on the recommendations made by the Prime Minister's Trade and Industry Council to the government in December last year. The move is in step with the decision of the government to simplify and reduce industrial clearances.

"The logic behind delicensing both the items is to avoid duplication since biotechnology is already covered under the Drugs Land Cosmetic Rules which have a central licensing system," officials said.

In addition, there is a genetic engineering approval committee under the ministry of environment and forests, and the drug Controller General of India which approves new drugs. "Since clearances from these three agencies will continue to be required, it was thought that there is no need for an industrial licence," they added.

Officials said there are now five items which would continue to require industrial licensing - distillation and brewing of alcoholic drinks, cigars and cigarettes of tobacco and manufacturing tobacco substitutes, electronic aerospace and defence equipment, industrial explosives and some categories of hazardous chemicals.

Industrial licence is granted by the Government of India for industrial assistance on the recommendations of the licensing committee.