Though the Central Drugs Standard Control Organisaton (CDSCO) has received representation against 12 pharmaceutical companies in the country for violation of laws related to quality control of drugs during 2010, many of the complaints could not be substantiated.
The CDSCO received complaints about Cupid Ltd of Sinnar near Nashik with regard to its condom product and the action was taken, according to the information collected by the Health Ministry. Complaint was received from Registrar of Copyright Office by CDSCO, West Zone in respect of Black Cobra Dotted Condoms, Ozomen Dotted Condoms and Bull Dotted Condoms. Investigation was carried out jointly by CDSCO and Maharastra FDA, officials. The samples were drawn and Black Cobra Dotted Condoms, Ozomen Dotted Condoms were found to be not of standard quality as declared by CDTL, Chennai. Reports were forwarded to SLA, Nashik Division for the administrative action and the license and production activities were suspended for 30 days.
Indian Embassy in Brussels, Belgium had sent a complaint against Wellbert Pharmaceuticals Pvt. Ltd., Navneet Shah Industrial Estate, Dadra, about the drugs Postinor tablet. Officers of CDSCO, West Zone along with State Drugs Control authorities had carried out surprise inspection/raid at the premises and the case has been handed over to police for further investigation. Police has filed a case in the Court of Law and arrested the owner and released on bail. The case is under further investigation by Crime Branch Police, Silvassa and the case is registered for violation of trade mark and forgery under section 420 of CrPC. Licence of the said firm was suspended with effect from February 11, 2010 by state authority, according to the report by CDSCO submitted to the ministry.
The case of not of standard quality oral insulin manufactured by Natco Pharma Ltd was investigated and on the basis of investigation new drug permission was suspended and prosecution permission was granted against the firm. On the basis of compliance report new drug permission for manufacturing was revoked on 31-12-2009, with the direction to draw fresh samples from new batches as per D&C Act. However, the government analyst CDL Kolkata has declared the samples to be of standard quality later, and cleared the case.
Based on complaint received through whistle blower scheme, a case was registered against Nitya Finechem Pvt Ltd of Kolukulapally in Andhra Pradesh. The case was already investigated and pertains to manufacture of Intermediates. Samples were collected and forwarded for testing against Narcotic and Psychotropic substances to Government Analyst. Reports have been received declaring that the samples were not containing any Narcotic and Psychotropic substances. The case is closed.
The joint investigation was carried out on 13/04/2010 by officials from CDSCO, Ahmedabad & FDCA, Gujarat and sample was taken from Globela Pharma, Surat in Gujarat. The sample was sent to CDL, Kolkata. FDCA, Gujrat has been requested to take further necessary action in the matter.
Another complaint received during the year was against J M Remedies, of Saproon in Solan district. The investigation was carried out by CDSCO North Zone and State Licensing Authority, H.P. Manufacturing license for 23 products was cancelled by State Licensing Authority, Himachal Pradesh vide letter No. HFW-H-Drugs-2009/2286 dated 18.10.2010.
Alliance Biotech from Nalagarh of HP also faced complaint. The investigation was carried out by CDSCO North Zone and State Licensing Authority, Himachal Pradesh. Samples, drawn from the manufacturing premises, were sent for tests at CDL, Kolkata. However all the samples were found to be of standard quality.
In the case of Progressive Life Sciences, Jhabera in Haridwar, investigation was carried out by CDSCO North Zone and State Licensing Authority, Uttarakhand. Production activity was suspended by the State Licensing Authority immediately. After re-inspection on 31.03.2010, stop production order was continued. However, a complaint against Albert David, Ghaziabad, about having toxic contamination in Ringer Lactate Solution could not be substantiated. Similarly, investigation was carried out by CDSCO North Zone and State Licensing Authority, Uttar Pradesh. The complaint regarding Toxic Contamination in Ringer Lactate Solution, B. No. G 85023 could not be substantiated.
Complaint regarding adverse drug reaction after administration of OPV batch No. PN 9065 by Panacea Biotec also could not be substantiated after CDSCO North Zone and Delhi Drug Control department held investigation. Another complaint was against Biomed Pvt. Ltd,Ghaziabad. The samples, collected by the authorities, were later declared as of standard quality by CDL, Kasauli in June, 2010.
“Investigation were carried out by CDSCO, South Zone at Symbiosis Pharma, Chennai having a valid sales license and samples drawn for test of FerogenXL, batch no. FX101 and CBS-120 tablets batch no CS101 manufactured by Amanath Pharmaceuticals, Puducherry. The samples were declared as not of standard quality. The State Licensing Authority, Puducherry suspended the license of Amanth Pharmaceuticals, Puducherry, for these products without prejudice to the legal action to be contemplated,” according to the report.