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Pharma SMEs seek rollback of mandatory submission of stability test for drug approval

Laxmi Yadav, Mumbai
Monday, February 11, 2019, 08:00 Hrs  [IST]

Expressing concern over mandatory submission of stability test for approval of all drugs, Small and Medium Pharma Manufacturers Association (SMPMA) has urged the Union health and family welfare ministry to rollback it by reinstating 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 a gazette notification.

The word-- patent or proprietary medicines in the said rules was replaced with word 'drug' by the health ministry through a gazette notification dated April 10, 2018 thus making it mandatory for pharmaceutical companies to submit stability studies for approval of all drugs.

Before April 10, 2018 notification, the said rules say, the applicant shall, while applying for a licence to manufacture patent or proprietary medicines, furnish to the licensing authority evidence and date justifying that the patent or proprietary medicines contain the constituent ingredients in therapeutic/prophylactic quantities as determined in relation to the claims or conditions for which the medicines are recommended for use or claimed to be useful and are stable under the conditions of storage recommended.

But GSR 360(E) dated April 10, 2018 through an amendment regarding the above states "That in sub-rule (6) in rule 71, rule 71B, sub-rule (7) in rule 76, rule 76A for the words "patent or proprietary medicines" at the places where they occur, the word "drugs" shall be substituted which has become mandatory for 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 SMPMA.

Those products which have been in the market for the last more than a decade (like tablet paracetamol, diclofenac, ibuprofen etc), trusted molecules manufactured by Indian pharmaceutical industry and tested on patients successfully need not be required to submit stability test for grant of license for new approvals of products, said Jain.

The better solution would be to have periodical stability studies from 6 to 18 months after manufacturer of the particular product and whatever new molecule introduced by industry shall adopt the your trial and test guidelines as well, he added.

SMPMA has appealed to the ministry to reinstate the word 'patents or proprietary' medicines in the D&C Rules, 1945 again by another gazette notification.

Madhya Pradesh Drug Manufacturers Association (MPDMA) has also expressed concern over the mandatory submission of stability studies for drug approval.

Himanshu Shah, president of MPDMA had on January 25, 2019 written to Laghu Udhyog Bharti to take up the issue with concerned regulatory authority.

The issue was also discussed at drug consultative committee (DCC) meeting recently.


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