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90% cough syrup manufacturing units inspected, lapses found, says drugs regulator
The Central Drugs Standard Control Organisation has inspected about 90% of the manufacturers of cough syrup in the country and found compliance lapses, Reuters quoted Drugs Controller General of India Rajeev Raghuvanshi as saying on Monday.
Speaking at the Global Pharmaceutical Quality Summit in Mumbai, Raghuvanshi also said that companies’ sites were being audited by the state and the central regulators under revised norms for good manufacturing practices and requirements, PTI reported.
His statements came months after a cough syrup contaminated with diethylene glycol was linked to the deaths of 25 children. The product, named Coldrif, was manufactured by Sresan Pharmaceuticals, which is based in Tamil Nadu’s Kancheepuram district.
The deaths, recorded beginning September 2, had been reported in Madhya Pradesh and Rajasthan. Several children, who had been suffering from fever and cold, consumed the Coldrif syrup, resulting in vomiting and difficulty urinating.
The Central Drugs Standard Control Organisation had come under pressure to tighten oversight of the $42 billion pharmaceutical industry after cough syrups made in India were linked to the deaths of more than 140 children in Africa and Central Asia since 2022, Reuters reported.
At the summit on Monday, Raghuvanshi said that there are more than 1,300 manufacturers of cough syrups, PTI reported.
“…Till now we have audited 1,250 of them physically going to their site, and as we do in risk-based inspection, we took serious actions on serious non-compliances,” the news agency quoted him as saying.
Raghuvanshi added: “Our belief is that the rot of cough syrup manufacturing will be removed from next season and we will be out of the issues of cough syrup manufacturing.”
The drugs controller general also said that about 850 Corrective and Preventive Action notices had been served to firms found manufacturing non-standard quality products, The Indian Express reported.
The notices are regulatory enforcement tools used by the Central Drugs Standard Control Organisation when products are found to be substandard during inspections, audits or after customer complaints.
“Not a single unsatisfactory CAPA has been accepted,” the newspaper quoted Raghuvanshi as saying.
The drugs controller general further noted that product recalls were compulsory in instances of quality failure. Enforcement actions range from the suspension of product licences to the cancellation and closure of facilities until deficiencies are corrected, he added.
Source: Scroll
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