Over 5000 fixed dose combinations, which were not approved by the Drug Controller General of India (DCGI) in respect of their safety and efficacy but granted licenses by the state licensing authorities, continue to be sold in the market, even as the regulatory authorities are now grappling with the question of how to verify them.

After the DCGI issued notices the manufacturers to submit safety data, as many as 5000 applications were received by his office, and many of them were found to be having no therapeutic justification or rationality for their marketing in the country, it is learnt.

In the face of the enormous number of applications and in the absence of detailed guidelines and procedures for the examination of these FDCs, the Drug Technical Advisory Board (DTAB) has recommended the formation of a sub-panel headed by Dr B Suresh, president of the Pharmacy Council of India, to give its recommendations and suggest guidelines for examinations of such FDCs and the action to be taken in such cases.

The State Licensing Authorities before granting the licence to manufacture such combination are required to ensure that the applicant has the approval in writing from DCG(I) as new drug. It was however, found that in many cases the State Licensing Authorities have granted licences for manufacture of fixed dose combinations falling under the definition of the new drug without prior approval from the DCG(I).

The Parliamentary Standing Committee on Health and Family Welfare in its 59th Report, while examining the functioning of CDSCO also examined the question of marketing of fixed dose combinations in the country. The Committee observed that the end result is that many FDCs in the market have not been tested for efficacy and safety. This can put patients at risk and to remove such unauthorized FDCs from the market, the Central Government can either issue directions under Section 33P to States to withdraw the licences of FDCs granted without prior DCG(I) approval or the Central Government can itself ban such FDCs under Section 26A.

“In view of the above the office of DCG(I) had written to all State / UTs Drugs Controllers on 15.01.2013 for directing the manufacturers in their States/UTs to prove the safety and efficacy of such FDCs before CDSCO within a period of 18 months, failing which such FDCs will be considered for being prohibited for manufacture and marketing in the country,” according to the minutes of the DTAB held on November 25.

“The applications received for grant of permission to market the FDCs considered as new drugs are examined by CDSCO in consultation with the New Drug Advisory Committees (NDACs) constituted by the Ministry of Health and Family Welfare. The office of DCG(I) in the meantime has received over five thousand application of the FDCs which have not been approved by the DCG(I) in respect of their safety and efficacy. Some of the FDCs were examined by the NDACs also. The NDACs while examining the FDCs have found certain FDCs do not have therapeutic justification or rationality for their marketing in the country. In view of this permission to market these FDCs were not granted. These FDCs are however, considered to be available in the market as these appear in the monthly indexes of medical specialties. In view of the large number of the applications guidelines and procedures are required to be prepared for the examination of the FDCs,” it said.