Madhya Pradesh Small Scale Drug Manufacturers Association patron, J R Agarwal, has urged DCGI Dr M Venkateshwarlu to order a CBI enquiry into the issuance and renewal of licenses for thousands of irrational combination drugs by the state drug authorities during the last more than three decades. Agarwal has threatened to file an FIR if action is not taken in this regard.

In a letter sent to DCGI, Agarwal said that the state drug authorities had issued product licenses for thousands of FDCs/New Drugs unauthorisedly. The companies of all sizes have been, thus, manufacturing and marketing these products for long without proper authorisation violating the rules.

"The crux of the matter is that State FDAs all over the country had issued product licenses for thousands of FDCs/New Drugs unauthorisedly and all these companies, mostly so called reputed, have been manufacturing and marketing these FDCs for nearly three decades in violation of the provisions of D&C Act/ Rules and rendered themselves liable for punishment accordingly," the letter said.

Agarwal, a senior industry professional engaged in Industrial Pharmacy and in SSI sector for nearly 38 years, urged the DCGI to order a CBI enquiry into the issue. "The act of all those state/UT FDA authorities granting/renewing such product licenses unauthorisedly must also be investigated by CBI and be acted upon as per law", Agarwal demanded in his letter.

Asking the DCGI to be firm in his action against the violation of law, the letter said, "I and the like minded professionals hope that you shall not be lenient in the matter and that necessary action as per law, irrespective of size or category of person(s) or company, would necessarily be initiated if not then I shall have to file PIL before the Hon'ble High Court".