Indian Drug Manufacturers Association (IDMA) has submitted a representation to the DCGI, Dr Surinder Singh requesting him  to grant import permission for dual purpose use of bulk drugs. This suggestion was submitted by the association at the meeting  held in Delhi on May 25 in which IDMA was invited by the DCGI to discuss the issue of import permission of dual purpose of bulk drugs.

The Association said that instead of bulk drug manufacturer's applying every time to the DCGI for import permit, they may be given import permit for one year. The representation states, “Actual user-importer of bulk drug for dual purpose should submit the data of the consumption of the imported bulk drug for manufacturing bulk drugs every year. And it should be their responsibility to make a fresh application for the renewal of import permit for dual purpose every year to DCGI's office.”

IDMA further suggested that the DCGI should ensure that if there is a new application for bulk drug for dual purpose, bulk drug manufacturer will have to furnish information as per the procedures and rules of the DCGI.

In the meeting, they also highlighted the issue of only a few dual purpose items being listed in the guidance document for grant of permission for drugs imported in the bulk for non medicinal use. IDMA has urged the DCGI to consider adding more products to the lists suitably so that it may help the industry.

Expressing their concern over providing only short duration for their suggestion, IDMA pointed out that the time given by the CDSCO for suggestion and approval should be extended as the stakeholders need to study the document properly.

The Association pointed out that the items enlisted in the guidance are only selective, since it has included only few amino acids and not all and has been completely silent on herbal extracts, enzymes and biological based products. IDMA is hopeful that the special committee set up by the DCGI will look into the issue and try to find out the solution soon.