Pharma industry braces for tighter manufacturing-linked norms

In just six months, reports of three major global incidents, including deaths, have been potentially linked to pharmaceutical products sourced from India. The incidents , have put local manufacturing practices and supply chain management under fresh scrutiny.

Since August 2022, “We believe there are approximately 300 deaths but data is still being collected from local authorities,” a World Health Organization spokesperson said. This includes the cough-syrup linked deaths reported from Gambia, Indonesia and Uzbekistan. Indian manufacturers Maiden Pharmaceuticals and Marion Biotech have been named in the Gambia and Uzbekistan incidents, respectively.

Last week, another incident in the US, saw the regulator red-flagging eye drops from Global Pharma Healthcare, following a potential bacterial contamination that resulted in adverse events and a death. The three incidents are in different stages of investigation.

Upgrade manufacturing

Pharma industry representatives said a policy directive is being discussed to “upgrade” present manufacturing practices to the World Health Organization’s cGMP (current Good Manufacturing Practices) levels. But not everyone is convinced that such “upgradation” would ensure quality products are supplied in the country and outside. Especially, since some of the companies in the dock now are reportedly WHO-GMP compliant.

It comes down to individuals involved in manufacturing and enforcement and the track record of companies, all of which can be mapped to showup habitual offenders or fix accountability when there’s an incident, said several pharma industry representatives who spoke to businessline , on conditions of anonymity.

The present Schedule M norms for manufacturing are stringent, and sometimes all that’s needed is technical hand-holding by regulators, or financial help to upgrade systems and documentation, said a long-time exporter to African markets, including Nigeria.

Nigerian experience

Industry voices point to the Nigerian experience, once fraught with tension following reports of fake products. That’s largely addressed, they said, with local agencies in India being appointed by the foreign regulator. The agencies get export consignments checked from reputed labs and the documentation is uploaded for the foreign regulators to check the consignment arriving on their shores.

In the Gambian incident, Indian authorities said that the control samples with the Sonipat-based Maiden Pharma did not contain the toxic contaminant diethylene glycol (DEG). However, the Gambain authorities and WHO, stood by their lab tests that showed DEG contamination.

Speedy action, better surveillance

S Srinivasan of Locost (a producer of less expensive drugs) points out, “In medicine, it is difficult to connect the dots,” but adds that a diligent documentation of raw materials, supply chain, etc can help fix accountability. Industry voices add, a quick and independent investigation, followed by graded penalties also helps build confidence in domestic and international markets.

WHO has called for increased surveillance and diligence within the supply chains of countries and regions likely to be affected by these products. Manufacturers of liquid dosage forms, especially syrups that contain excipients including propylene glycol, polyethylene glycol, sorbitol, and glycerin/glycerol, have been urged to test for contaminants such as ethylene glycol and DEG before using in manufacturing of medicines. “Increased surveillance of the informal/unregulated market is also advised,” said the UN-health agency’s spokesperson.

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