Mumbai: Controversy is coming the way of Ajanta Pharma as the firm has come under the CDSCO scanner for allegedly selling unapproved FDCs.
It is reported that a pharma manufacturing firm Safetab Life Sciences was recently raided by Central Drugs Standard Control Organisation (CDSCO) officers along with south zone drug inspectors from 9-11 July following a tip-off that the firm was manufacturing unapproved FDCs.
The CDSCO sleuths found 30 FDCs were manufactured without permission from the Drug Controller General of India (DCGI) and were labelled as marketed by M/s Ajanta Pharma Ltd, Aurangabad, Maharashtra.
A person aware of the matter told Mint, “While a complaint has been lodged with the local police against Puducherry-based Safetab Life Sciences, the regulator is investigating the role of Ajanta Pharma so that appropriate action can be taken against the company.”
During the investigation, the team found that the firm was manufacturing two strengths of diabetes drugs Voglibose (Volga R 0.3mg/0.5mg) and Repaglinide (0.3 mg /1 mg) was found manufacturing without license by the investigating team. Currently, the FDCs of Repaglinide and Voglibose are not approved for manufacturing and marketing in the country.
According to the daily, the clinical trial permission for these FDC combinations was issued in June 2016 to another firm and these trials are not yet over.
Speaking with Mint another person aware of the matter said “The safety and efficacy of the FDC data would be evaluated after the trial is completed. The investigation team seized Repaglinide bulk drug, printed aluminium foils and cartons, control samples of the bulk drug and control samples of the finished product. The team also has seized batch manufacturing records, purchase and sale invoices etc.”
A complaint has filed with the local police by the drug regulating authorities. According to the provisions of Drugs and Cosmetics Act, the infringement attracts up to five years imprisonment and a fine.
An Ajanta Pharma spokesperson told Mint, “We have not received any communication from the office of Drug Controller General of India in this regard. Ajanta Pharma markets some of the drugs of Safetab Life Sciences for which they have the requisite licence from the local Food and Drug Administration.”
Medical Dialogues had earlier reported that the CDSCO had conducted raids at two firms based in Haridwar and Roorkee and is mulling cancellation of their licenses for manufacturing and selling medicines without approval from the drug regulator