The latest news from the Indian pharma sector, including the potential for greater numbers of exports and better market access to the UK under a proposed free trade agreement, yet another scandal – this time over contaminated cough syrup in Gambia –, and why 200 million doses of Bharat Biotech’s COVID-19 vaccine Covaxin may have to be destroyed next year.
India looking at greater market access for pharma products in UK under proposed FTA: Official (Economic Times Healthworld)
India looking at greater market access for pharma products in UK under proposed FTA: OfficialNew Delhi: India is looking at greater market access for its pharmaceutical products in the UK as part of the proposed free trade agreement with Britain, an official said on Friday. The official also said that a leaked chapter of the agreement, which is floated on some portals, on intellectual property (IP) is edited, distorted, and is a manipulated version of an initial document of the UK.
“The best part in the proposed agreement is that both sides have highlighted their red lines and sensitivities. Ever-greening and touching manufacturing of generic medicines is completely non-negotiable,” the official added.
IAG Cargo eyes growing India pharma exports to UK and Europe as India-UK trade deal looms (Economic Times Infra)
India and the United Kingdom are negotiating a comprehensive trade deal which is expected to bolster the economic relations between the fifth and sixth largest economies of the world. According to reports, pharmaceuticals are among the several sectors on which trade negotiations are ongoing.
India’s massive pharma industry hounded by scandals (DW)
The recent deaths of 66 children in Gambia put the spotlight on India’s drug manufacturers following reports that the children’s condition deteriorated after they were given Indian-made cough syrup. The syrup was manufactured by India’s Maiden Pharmaceuticals and exported to the African country under four different brands. The World Health Organization (WHO) warned that the products were “contaminated” and triggered symptoms including “abdominal pain, vomiting, diarrhea, inability to pass urine, headache, altered mental state, and acute kidney injury which may lead to death.”
Maiden Pharmaceuticals responded by saying it was “diligently following the protocols of the health authorities” in their production process, and was “shocked” and “deeply saddened” by the incident.
FDA warning letters detail issues for manufacturing sites in the US and India (Endpoints News)
India-based generics giant Lupin was also hit with a warning letter for its plant in Tarapur, India, with the letter unveiling that the company had not established written procedures for cleaning equipment for manufacturing APIs.
Lupin had notified the Indian stock exchange of the letter in early October.
FDA revealed that Lupin also didn’t have written procedures to monitor the progress of “processing steps” that may cause “variability” in the quality of the ingredients as well as not properly investigating all “critical deviations.”
Poor Demand, Over 200 Million Covaxin Shots May Expire: Report (India.com)
Even as we’ve seen multiple reports of Bharat Biotech’s Covaxin being equally and sometimes even more effective than its peers against Covid-19 and several of its variants, a fresh report has suggested that millions of doses of the vaccine are set to expire early next year.
More than 200 million doses of the Indian made Covaxin in its bulk form and 50 million doses in vials will expire in early 2023, ET quoted a person in the know. The same person said the company had stopped production earlier this year.