The Andhra Pradesh Drug Control Administration (APDCA) has recently filed a case against MacMohan Pharma director in the court for illegally involved in manufacturing, packing and distributing ‘Thalidomide capsules USP 100 mg’ to MNJ Institute of Oncology through its sister concern Amaranco Lifesciences in Hyderabad.
After an investigation of two long years since June 2010, APDCA has finally gathered enough evidence to nail the company in the court of law at XII Additional Chief Metropolitan Magistrate at Nampally and filed a case against Y. Anil Mohan Rao, director of MacMohan Pharma and Amaranco Lifesciences for violating the Drugs And Cosmetic Act 1940 and involving in spurious drug manufacturing activity in the state.
According to sources, Anil Mohan Rao was involved in manufacturing and selling spurious drug Thalidomide capsule USP 100mg and falsely claimed to manufacture as if it is their own product. He has been booked for repacking and sale of Thalidomide capsules to MNJ Institute of Oncology and Regional Cancer Centre (MNJIO&RCC) at Red Hills in Hyderabad.
The DCA had also booked the director for two more counts. First count is for his involvement in sale of misbranded drugs as the labels on the packed bottles were not mentioned the manufacturer's name or the license number. Secondly, he had been held at fault for manufacture/sale of Thalidomide capsule USP 100mg with modified claims and indications other than what it was approved for by Drugs Controller General of India. In fact Thalidomide was approved for marketing with the claim for the treatment of leprosy but the firm has manufactured and sold it with an indication for multiple myeloma.
Sources said the issue came to light when DCA officials inspected the main medical stores at MNJ Institute of Oncology in 2010 to verify the purchase, receipts, distribution and storage of oncology drugs.
“During our inspection, we found that the drug ‘Thalidomide capsules USP 100 mg’ was packed in HDPE (High Density Polyethylene Hard Plastic) bottle pack bearing label indicating batch no 090907 with manufactured date September 2009. we also came to know that it was marketed by Amaranco life sciences Ltd, but were surprised for not finding the manufacturers name and the license number on the labels of the bottle pack which was unusual and a contravention of the provisions of section 17 which falls under the ambit of Misbranded drug of D&C Act 1940,” revealed an inspecting officer.
“Upon verifying the documents at the stores we could ascertain that MacMohan Pharma Ltd at Jeedimetla was illegally manufacturing different batches of Thalidomide capsules without possessing any valid drug license for the manufacturing, repacking or selling the drug. Having resorted to spurious activity of illegal selling and distributing without license they have violated Section 18 (c) of the Act,” added the officer.
Earlier the officials had sent the drug to drugs control laboratory to analyze its contents and have later confirmed that it contains the same ingredient. So there is no problem with the drug ingredient but the problem is with the illegal and unlicensed manufacture, violating which is punishable under Drugs And Cosmetic Act 1940.
Further officials revealed that MacMohan Pharma had procured the basic raw material (active pharmaceutical ingredients) for Thalidomode USP from Shilpa Medicare Limited in Raichur and repacked it in the form of capsules and sold the same capsules to MNJ Cancer Hospital.
Having busted this illegal activity of MacMohan Pharma, the officials had alerted MNJ Institute of Oncology and Regional Cancer Centre at Red Hills and cautioned them to verify the drug licenses copies and other related documents from their distributors before they procure the drugs.