410 drug units fear closure if GMP deadline not extended

Tribune News Service

Ambika Sharma

Solan, March 9

As many as 410 pharma micro, small and medium enterprises (MSME) will have to close operations if the Central Government doesn’t extend the timeline for the implementation of revised good manufacturing practices (GMP) within a year.

Exit road map

• The Himachal Drug Manufacturers Association has sought an exit road map for the MSMEs that fail to invest amounts between Rs 3 crore and Rs 10 crore for upgrading their manufacturing facilities

To ensure quality drugs, companies having an annual turnover of over Rs 250 crore will have to adopt GMP within six months while small and medium manufacturers have been given an year to adopt the same. The adoption of these norms will bring units on a par with the World Health Organisation standards.

Those failing to comply with modifications will be penalised or their licences will be suspended. The norms have been implemented after a notification of the revised Schedule M of the Drugs and Cosmetics Act on December 28 by the Health Ministry.

In Himachal, out of 665 pharma units, 255 are WHO-GMP certified and have European Union-GMP and other international certifications like USFDA. The remaining 410 working under the existing Schedule M rules are supposed to upgrade as per the revised GMP norms till December end or else could face closure.

“These 410 pharmaceutical units will be forced to close as one year is a short time to implement revised norms. Design and planning alone would consume three months. Even after adopting the revised norms, validation activities will consume another three months. Barely six months will be left to execute changes in a running unit having ample funds,” said Dr Rajesh Gupta, president, Himachal Drug Manufacturers Association.

“The plight of units lacking adequate funds will worsen as they face a headache of arranging requisite funds within the time frame,” he said.

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