GMP, NSQ compliance: MSME pharmaceutical companies seek financial aid

Pharma MSMEs seek Rs 50 crore handholding and extension for GMP compliance under revised Schedule M, citing challenges in adhering to regulatory and quality standards

Several pharmaceutical companies and associations raised concerns over the regulatory and financial issues faced by small and medium units in complying with good manufacturing practices (GMP) during a consultation with NITI Aayog on Monday.

 

According to people in the know, MSME pharma players have asked the drug regulator for handholding companies with turnover below ₹50 crore and a further extension for complying with revised Schedule M, which outlines GMP for pharmaceutical units.

 

This request comes after small units with an annual turnover of less than or equal to ₹250 crore were granted a one-year extension to comply with the revised Schedule M.

 

However, all units under this criterion were required to submit a gap analysis plan to the Central Drugs Standard Control Organisation (CDSCO) by May 30 to qualify for the extension. According to industry insiders, only 1,600 units out of 8,500 MSME pharma units have submitted the plan to the drug regulator.

 

Several groups, such as the Confederation of Indian Pharmaceutical Industry (CIPI), have previously written letters to the CDSCO and the Union Health Secretary, requesting an extension of the deadline for submitting gap analysis plans to August.

 

According to industry sources who attended the meeting, Drug Controller General of India (DCGI) Rajeev Singh Raghuvanshi stated that there would be no relaxation in the enforcement of GMP.

 

“He also expressed disappointment with the role of pharma manufacturing associations, urging them to take more responsibility in ensuring that member units uphold quality norms,” an executive added. 

 

A group of pharmaceutical associations has also endorsed a GMP-linked support scheme and the establishment of common quality assurance infrastructure for MSME pharma clusters.

 

This comes amid rising concerns over the increase in the number of "Not of Standard Quality" (NSQ) drug alerts.

 

An executive noted that the DCGI outlined a stricter protocol for handling NSQ cases, with companies now facing license suspension after a two-week showcause notice. Reinstatement of such companies will only be considered after a satisfactory Corrective and Preventive Action (CAPA) review.

 

Industry representatives also highlighted the issue of poor educational standards in pharmacy colleges, which may result in technically underqualified personnel unable to handle drug inspectors during audits.

 

Representatives for CIPI also proposed the setting up of financial support for equipping the MSME industry with infrastructure to conduct stability studies, helping to reduce incidents of NSQ.

 

Other issues discussed included quality-linked pricing and procurement, as well as strengthening post-marketing surveillance and pharmacovigilance.

 

Commenting on the issue, Nikkhil K. Masurkar, Chief Executive Officer (CEO) of Mumbai-based Entod Pharmaceuticals, said that NITI Aayog’s call for a quality overhaul is both timely and necessary.

 

“While India has made remarkable strides as a global pharma hub, maintaining consistent, internationally acceptable quality standards remains a key challenge, especially among MSME companies,” he added.