Karnataka Drugs and Pharmaceutical Manufacturers Association (KDPMA)  has brought to the notice of the Drugs Controller General of India that several unapproved fixed dose combinations (FDCs) are in circulation in the central and state government hospital supply chain.

These include the ESI Corporation of India, Jan Aushadi outlets of Bureau of Pharma Public Sector Undertakings of India (BPPI), under the department of Pharmaceuticals, Karnataka State Drugs Logistics & Warehousing Society, Directorate of Medical Education & Research, Maharashtra, Chhattisgarh Medical Education Corporation, Director General Armed Forces Medical Services, New Delhi among others.

This is despite the need for a CDSCO approval for all the FDCs based on the three circulars and advisories via:  F. No. 4-01/2013-DC (Mics.13-PSC) DT15.13. Directions under Section 33 P No. X110 11/12011-DFQCDT 1.10.12 and F No. 4-01/2013 DC (Misc.13 PSC) dated 5.7.13, pointed out KDPMA in its representation.

KDPMA in its representation to the DCGI said, “Firstly our members representing KDPMA have submitted safety and efficacy studies of the unapproved FDCs in Form 44 with requisite fees. Secondly, most of the state licensing authorities (SLAs) have stopped granting permissions for unapproved FDCs with effect from October 1, 2012”.

“Now, we would also bring to your notice that several reputed government hospital departments and institutions are purchasing drugs which include FDCs that have so far not been approved by DCGI for their mass public health programmes. These unapproved FDCs are being purchased since a long time and in huge quantities,” said the representation.

The repeated purchases of these FDCs are being made after due approval of the respective Therapeutic Committees comprising eminent experts, civil servants, regulators, among others. “We understand that the continuing purchases are made due to the need and proven clinical efficacy along with safety parameters of the FDCs benefitting very large number of patients,” said Jatish N Seth, president, KDPMA and signatory to the representation.

Most state licensing authorities have, already stopped issuing permissions for FDCs and any new company or even an existing company wanting to introduce FDCs are not able to participate in these central and state government tenders. Terming the move as discriminatory, the KDPMA president pointed out that it deprived the consumer of a fair competition and price.

In view of the current circulation of FDCs in the central and state hospital supply chain, KDPMA said that it requested DCGI to provide the permission to the state licensing authorities to permit the approval of these drugs.