Of 655 pharmaceutical units, mere 122 register for upgrade in state

Despite manufacturing every third drug in the domestic market, the state’s pharmaceutical industry is battling a major crisis.

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Reason: Only 18 per cent units have registered for the revised Schedule M stipulation of the Good Manufacturing Practices (GMP) norms by May 11.

The norm made mandatory by the Ministry of Health and Family Welfare in December 2023 had been conditionally extended for the small and medium manufacturers having turnover of Rs 250 crores or less, up to December end.

Though the industry had sought extension to improve their infrastructure, training of personnel and arranging financial resources, they were required to submit their plan for upgrading their unit before the central licence approving authority by May 11 to convey their seriousness.

Once upgraded, it will bring them on a par with the global World Health Organisation’s manufacturing standards .

The large manufacturers, having turnover of more than 250 crores have, however, implemented the norm by June 2024. Majority of the firms fall under the Micro Small and Medium Enterprises (MSME) category.

One can gauge the dismal scenario from the fact that out of the 655 pharmaceutical firms barely 122 have registered for upgrade, thus putting a question mark on the remaining units. The scenario was equally dismal nationally where among 6,000 micro small and medium sector pharmaceutical firms only 1,246 have applied for the extension till mid-June.

The revised norms have been enforced to ensure the quality and safety of pharmaceutical products being manufactured in India while strengthening their domestic position.

Several cases of global drug recalls and domestic cough syrups causing infant mortality abroad have adversely hit the image of the nation’s pharma industry, thus prompting the authorities to introduce stringent norm.

Contrary to these mandates, the MSMEs rue that they were unable to arrange the requisite funds amounting to crores to implement the new norms.

A manufacturer will have to implement a slew of modifications related to manufacturing premises, plant and equipment, product quality review, pharmaceutical quality system, quality risk management and computerised storage systems.

Besides, improvement in quality risk management , data integrity principles ensuring that data is reliable, trustworthy, and can be traced back to its source and pharma covigilance mandating for adverse event tracking have to be introduced.

“Barely 122 of the 655 pharmaceutical units in Himachal have submitted their plan for upgrade,” said Sanjay Sharma, general secretary of the Himachal Drug Manufacturers’ Association.

The left-over firms are fearful of adverse backlash like stringent Reserve Bank of India actions and an uncertain future.

He added that those who have registered for the upgrade were also having anxious moments as there were doubts whether added cost incurred through loans can be recovered in time or not.

With cases of drug samples failing quality parameters coming to the fore, the need to introduce quality was a key concern. It remains to be seen how firms balance quality with cost to sustain the consumer’s confidence.