Health Ministry Sets Up Sub-Committee To Frame Guidelines On Stability Studies Data

Mumbai, 7 March 2019: The Drugs Consultative Committee (DCC) of the Union health ministry has set up a sub-committee under the chairmanship of Punjab drugs controller Pardeep Kumar Mattu to frame guidelines on acceptance of stability studies data, generated by the applicant drug manufacturers under the licence in Form-29 or data generated by the manufacturers in the formulation research and development (FRD)/formulation and development (F&D), etc, for grant of permission to manufacture drugs formulations.

As per two letters issued by Drugs Controller general of India (DCGI) on December 8, 2018 and December 12, 2018, in order to get permission to manufacture drug formulations, manufacturers are required to submit stability data for six months for the existing products & stability data for three months for products declared as rational by Kokate Committee. 

Certain difficulties have been foreseen in the implementation of the instructions of these two letters, whether the state licensing authorities shall consider the data generated by the applicant manufacturer under the licence in Form-29 or data generated by the manufacturer in the FRD/F&D and so on. 

In a bid to come out with necessary clarification in this regard, a six-member sub-committee has been constituted by the DCC at its 55th meet on January 31-February 1, 2019. The committee comprising of Dr Preeti Meena, director of Telangana Drugs Control Administration, NK Ahuja, Drugs Controller, Haryana, deputy drugs controller, CDSCO R Ramkrishna, Prof Goyal (pharmacy-Ahmedabad) and two formulation experts will examine the issue in its upcoming meeting and submit its recommendation to DCC for consideration.

Further, the disparity between the periods mentioned in the letters has created a confusion among the regulators as well as the manufacturers regarding their justification, that why both are not at par with each other. 

The DCGI issued letters to state drugs controllers in December last year following Union health and family welfare ministry's circular dated April 10, 2018 which replaced the word 'patent or proprietary medicines' in sub-rule (6) in rule 71, rule 71B, sub-rule (7) in rule 76, rule 76A in Drugs and Cosmetics Rules, 1945 by the word 'drugs' through an amendment. Hence, it has become mandatory for pharmaceutical companies to submit stability studies for approval of all drugs. 

Drug manufacturers have expressed concern over mandatory submission of stability test for approval of all drugs. 

“This is indeed a big challenge for existing as well as new manufacturers and becomes a hurdle for implementing the mission "Make in India" to invite new plant, will badly affect the export and unit in the pharmaceutical sector. Because due to this it shall take minimum 8 to 9 months to finish stability test and get product approval of molecules for commercial production for the new as well as existing manufacturing units, a delay which shall put a huge financial burden,” said Nipun Jain, chairman of Small and Medium Pharma Manufacturers Association (SMPMA).  Pharmabiz