Mumbai: Ajanta Pharma Ltd has come under the regulator’s scanner for allegedly selling unapproved fixed-dose combinations (FDCs) manufactured by a Puducherry firm.

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," said two people aware of the matter, requesting anonymity.

Central Drugs Standard Control Organisation (CDSCO) officers along with south zone drug inspectors raided Safetab Life Sciences premises from 9-11 July following a tip-off that the firm was manufacturing unapproved FDCs.

Investigators have indentified about 30 FDCs, which they say were manufactured without permission from the Drug Controller General of India (DCGI). “The drugs were manufactured without licence and labelled as marketed by M/s Ajanta Pharma Ltd, Aurangabad, Maharashtra," added the first person quoted above.

The investigation 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) without license. Importantly, the FDCs of Repaglinide and Voglibose are not approved for manufacturing and marketing in the country. According to people in know, the clinical trial permission was issued in June 2016 to another firm and these trials are not yet over.

“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," said the second person. The drug regulating authorities have filed a complaint with the local police. According to the provisions of Drugs and Cosmetics Act, the contravention attracts up to five years’ imprisonment and a fine. Safetab Life Sciences could not be contacted immediately. Calls made to the MD remained unanswered

CDSCO is taking a strict approach after a parliamentary standing committee report came down heavily on its functioning, finding that many FDCs were arbitrarily approved without anyone conducting clinical trials. The report suggested that many combinations were approved by state drug authorities without the nod of the DCGI. According to the report a total of 31 new drugs were approved between January 2008 and October 2010 without clinical trials on Indian patients.

The recent investigations are a follow up to raids conducted under Drug Controller General of India Dr S. Eswara Reddy. CDSCO has also raided manufacturing plants in Haridwar and Roorkee (Uttarakhand) and found that they were making drugs without the approval of the Central drug authority. Over 70 of 118 products were found to have been made without the DCGI’s approval.

An Ajanta Pharma spokesperson said, “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.

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