Revised GMP norms for pharma firms to kick in from January 1

Revised guidelines propose major improvements in physical infrastructure, air handling units and equipment and machinery.

good manufacturing practices, GMP, pharma, healthcare, health, National Pharmaceutical Pricing Authority, NPPA, Drugs Controller General of India, DCGI
The norms have define lot of things required in terms of the systems and processes as well. (Image/Freepik)

With the revised Schedule M guidelines for good manufacturing practices (GMP) to come into force from January 2025, and there’s no likely extension of the deadline for meeting the new norms, the pharma sector is staring at a crisis situation. Experts said that without price hikes, the companies will not be able to comply with the stricter norms.

As per estimates, just about 2,000 pharma units in the country are compliant with the WHO’s GMP norms out of the total 10,500 drug manufacturing units. Nearly 80% of the 10,500 units are MSMEs, many of whom are still non-compliant and run the risk of possible shut down.

Even though the pharma associations still expect an extension, sources told FE that the government is unlikely to budge. “The deadline given to the MSMEs is going to lapse by December-end. The industry was given sufficient time to adhere to the new norms,” said a senior official.

In fact, just last month, Drugs Controller General of India (DCGI) at the Central Drugs Standard Control Organisation (CDSCO) Rajeev Singh Raghuvanshi told pharma companies to align with the value chain and audit requirements as per Schedule M or risk non-compliance.

“We are still hopeful of an extension. The industry is not ready and we need more time to comply. So far, we have not got replies on our petitions to the health minister and health secretary asking for an extension,” said head of pharma association.

Experts said that the impact of the new norms can be mitigated by price hikes, and the industry must be supported by the government to increase prices. “We must also look at price hikes so that the industry can meet and maintain these standards in the long run. The National Pharmaceutical Pricing Authority (NPPA) guidelines also need to look into the impact of these standards and how it can be made viable for the industry to survive. We will also need in terms of subsidies low-cost loans to implement this initially,” said Saurabh Arora, managing director at Auriga Research.

In order to curb NSQ (non-standard quality), government notified revised schedule M norms in December 2023 whereby the drugmakers with an annual turnover of over Rs 250 crore had to compulsorily follow GMP within six months while those with a turnover below Rs 250 crore were supposed to do so over a 12-month period.

Revised guidelines propose major improvements in physical infrastructure, air handling units and equipment and machinery. The norms have define lot of things required in terms of the systems and processes as well. 

“There is a clear-cut requirement to have product development reports, process validation studies, method validation studies and lot of other requirements which were earlier not so explicitly defined. Even after the marketing, there is a requirement for pharmacovigilance and post marketing studies,” said an industry analyst.

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This article was first uploaded on December thirty-one, twenty twenty-four, at fifteen minutes past twelve in the am.
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