CHENNAI: Sresan Pharmaceuticals , the manufacturer of toxic Coldrif cough syrup, purchased non-pharmaceutical grade of propylene glycol - a raw material for manufacture of drugs - but there was no invoice for the purchase, found drug inspectors who visited the company's Kancheepuram unit in Tamil Nadu on October 2.
Four other syrups manufactured with propylene glycol as an excipient (medium for the drug) were found to be safe. Senior drug inspectors P Nithin Kumar in Kancheepuram and R Sasikumar in Thiruvallur found that the medicines in the unit were stored under " unhygienic conditions " - placed in corridors, and filled, labelled and dedusted in areas without air handling units. There were no pest control measures, purified water generation system or cleaning procedures in place. Equipment in the unit was rusty, cracked and leaking. Many other violations, including the risk of contamination, were listed in the 20-page report.
Sriperumbudur drug control inspector Manimegalai issued a show-cause notice to the company Tuesday afternoon, asking it to explain the discrepancies in the medicine's quality and labelling. A police team from MP is likely to visit the facility Wednesday.
While a case against the company proprietor, G Ranganathan, has been filed by MP government , Tamil Nadu health department is yet to initiate action against the drug inspectors who permitted the unit to produce drugs in such unsafe conditions. "If they could list so many issues after a single inspection, why was the unit allowed to function?" asked former state drug controller M Bhaskaran.
A release from the Tamil Nadu directorate of drugs control said despite October 1 and October 2 being public holidays, the inspection of the manufacturing facility began just hours after receiving MP's request. The entire investigation was completed within two days, it said. The state drugs control department said there were no cases pending against him. Bhaskaran says that's because "no one kept track or inspected the premises".
Ranganathan, 73, a pharmacy graduate from Madras Medical College , built his reputation over more than four decades as the man behind Pronit, a nutritional syrup that became popular in the 1980s. Its success was interrupted when the state drug control department intervened: the product was promoted as a 'nutritional food supplement', but the ingredients used in its making required prior approval from the state drug control department. Ranganathan was then forced to obtain a proper licence, regularising the product. Over the years, he came to head Sresan Pharmaceuticals.
Now, his 2,000 sq ft unit along the Chennai-Bengaluru highway has been sealed, and his registered office in Kodambakkam remains locked. Employees were seen moving out equipment and computers late at night. A lone security guard now redirects all visitors to Ranganathan's lawyer, who refuses to disclose any details.
Four other syrups manufactured with propylene glycol as an excipient (medium for the drug) were found to be safe. Senior drug inspectors P Nithin Kumar in Kancheepuram and R Sasikumar in Thiruvallur found that the medicines in the unit were stored under " unhygienic conditions " - placed in corridors, and filled, labelled and dedusted in areas without air handling units. There were no pest control measures, purified water generation system or cleaning procedures in place. Equipment in the unit was rusty, cracked and leaking. Many other violations, including the risk of contamination, were listed in the 20-page report.
Sriperumbudur drug control inspector Manimegalai issued a show-cause notice to the company Tuesday afternoon, asking it to explain the discrepancies in the medicine's quality and labelling. A police team from MP is likely to visit the facility Wednesday.
While a case against the company proprietor, G Ranganathan, has been filed by MP government , Tamil Nadu health department is yet to initiate action against the drug inspectors who permitted the unit to produce drugs in such unsafe conditions. "If they could list so many issues after a single inspection, why was the unit allowed to function?" asked former state drug controller M Bhaskaran.
A release from the Tamil Nadu directorate of drugs control said despite October 1 and October 2 being public holidays, the inspection of the manufacturing facility began just hours after receiving MP's request. The entire investigation was completed within two days, it said. The state drugs control department said there were no cases pending against him. Bhaskaran says that's because "no one kept track or inspected the premises".
Ranganathan, 73, a pharmacy graduate from Madras Medical College , built his reputation over more than four decades as the man behind Pronit, a nutritional syrup that became popular in the 1980s. Its success was interrupted when the state drug control department intervened: the product was promoted as a 'nutritional food supplement', but the ingredients used in its making required prior approval from the state drug control department. Ranganathan was then forced to obtain a proper licence, regularising the product. Over the years, he came to head Sresan Pharmaceuticals.
Now, his 2,000 sq ft unit along the Chennai-Bengaluru highway has been sealed, and his registered office in Kodambakkam remains locked. Employees were seen moving out equipment and computers late at night. A lone security guard now redirects all visitors to Ranganathan's lawyer, who refuses to disclose any details.
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