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India Will Require Annual Supplier Audits To Be done By Pharmaceutical Companies

India Will Require Annual Supplier Audits To Be done By Pharmaceutical Companies
According to a government document, India will strengthen regulations and require medicine manufacturers to audit their raw material suppliers at least once a year after Indian cough syrups were found to be responsible for 141 child fatalities globally.
The new regulation, coupled with stricter testing requirements for exports of cough syrup put into place in June, demonstrate India's efforts to reassure customers about the security of its $42 billion pharmaceuticals sector, one of the biggest in the world.
The World Health Organisation (WHO) and other health organisations have connected the deaths of 70 children in the Gambia, 65 in Uzbekistan, and at least six in Cameroon over the past year to tainted cough syrups made in India.
In a meeting with representatives from the sector on September 15, the Central Drugs Standard Control Organisation (CDSCO), India's federal drug regulator, reportedly announced the plan to require audits of raw material and packaging suppliers.
According to the presentation, drugmakers would need to audit their raw material and packaging suppliers "at least once a year". Currently, such audits are conducted sporadically following occurrences like product recalls, it said.
There were no comments available on the issue from India's Health Ministry.
According to Reuters, some Indian pharmaceutical companies were purchasing essential chemicals from vendors who lacked a licence to market pharmaceutical-grade goods. Drug manufacturers have refuted claims that deaths were caused by their drugs.
The letter stated that medication manufacturers would also be required to notify their licencing bodies, often the state's drug regulator, of any product recalls.
After several Indian companies received medicine export licences from their home state despite prior violations in other states, health authorities condemned the absence of information on product recalls.
The WHO claims that a wave of drug poisoning caused by India-made medications may have started with the death of 12 youngsters in India in late 2019 after they ingested tainted cough syrup.
The syrups were discovered to contain toxic diethylene glycol (DEG) and/or ethylene glycol in significant concentrations in each of the cases.
India intends to increase "trust and confidence on quality" and decrease "product failure" among other things through the new regulatory procedures for pharmaceutical items, according to the presentation.
Separately, a statement from the trade organisation supported by the trade ministry, the Pharmaceuticals Export Promotion Council of India (Pharmexcil), stated that the trade ministry has been holding workshops across the nation for drugmakers to "review the regulatory perspectives on DEG contamination and discuss the current regulations in place to prevent it".
"Maintaining the quality of pharmaceutical products is crucial to guaranteeing the patient's safety, failing which could have long-term ramifications for the global public's confidence on Indian medicines," Pharmexcil said.
"The Indian pharma units, especially the MSME (small companies) sector are facing new challenges under resource-poor settings to meet global as well as domestic healthcare expectations."

Christopher J. Mitchell

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