The Maharashtra FDA cancelled manufacturing licenses of 5 pharmaceutical companies for allegedly manufacturing misbranded and spurious drugs and also for illegal export of pharmaceuticals to Nigeria.
The manufacturing license of National Pharmaceuticals, Tarapur, has been cancelled for manufacturing Tramal Capsules (Trmadol HCL-‘habit forming’ analgesic capsules), a registered brand of Sanofi Synthelabo, Germany and Positron tablets (oral contraceptive), registered brand of Gedeon Ritcher Ltd., Hungary. The analytical report of Positron tablet revealed that the tablet does not have Levonogestrol, the major ingredient in oral contraceptive but found to be contained chloropheniramine maleate (anti-allergic) as active ingredient. The drug inspectors seized the stock of 16,200 Tramal capsules-50 mg, 42,500 Positron tablets. Total cost of the seized drug is more than 1 lakh. The prices in the Nigerian market, where it is meant to be exported, will be more than 5 times of the Indian prices, H D Salunke, joint commissioner, FDA Maharashtra, who leads investigation of the case told Pharmabiz. The company officials concerned were arrested by the police and charged under section 27 of Drugs and cosmetics Act 1940.
Another Vile Parle-based company, Vipra Pharma, was found to be indulged in illegal export of various drugs to Nigeria. It had purchased basic drug, sidenafil citrate from a Mumbai-based company and delivered it with printing and packing material to Altek Pharmaceuticals, Thane for manufacturing ‘One up tablet.’ A quantity of 71,000 tablets was seized by drug inspectors. The officials of the two companies were charged for manufacturing drugs without license, exporting illegally and sold without sales bills. Drug manufacturing licenses of the two companies were cancelled.
Aeries Pharmaceuticals, Mira Road, has been found to be indulged in illegal manufacturing and export of Tramal Capsules to Nigeria. The company manufactured 23 lakh capsules from March 2005 to August 2005 without keeping required manufacturing and testing records as per schedule U of Drugs & Cosmetics Act 1940, FDA officials said. It was found that the drugs were exported to Nigeria through Bharati Overseas, Mira Road without export documents. The drug manufacturing license of Aeries Pharmaceuticals has been cancelled and a show-cause notice for cancellation of selling license has been issued to Bharati Overseas.
More companies are likely to be involved in the nexus and will be charged as the investigation is progressing, FDA sources told Pharmabiz. The illegal business of the companies was unearthed when two Nigerians were arrested with Tramal capsules and Positron tablets two months back.