The Kerala Medical Services Corporation (KMSC Ltd) has disqualified and blacklisted three pharma companies for breaching tender conditions and terminated their supply contracts with the Corporation. These companies cannot participate in the tender processes of the KMSCL in the next three financial years from 2010-2011.
Erica Nirmaya Ethicals Pvt. Ltd., Mumbai, Medipol Pharmaceutical India Pvt. Ltd., Delhi and Agron Remedies Pvt Ltd., Kashipur (Uttarakhand) are the companies that have been blacklisted by the KMSCL for violation of tender conditions and Schedule M of the Drugs and Cosmetics Rules, 1945.
According to Biju Prabhakar, the managing director of KMSC Ltd, the Erica Nirmaya Ethicals could not execute the purchase orders within the stipulated time reportedly because of their internal company problems. The company was awarded supply contracts for tablets ciprofloxacin 500 mg, azithromycin 250 mg, azithromycin 500 mg and fluconazole 150 mg as the eligible lowest bidder for 2010-2011. Based on the tender, the company had executed an agreement with the medical corporation for supply of the products. But the company could not supply any quantity of the orders within the purchase order period. Accordingly, after repeated reminders and official proceedings, the KMSC has terminated the agreement and blacklisted the company for next three years. The Corporation has also declared that Erica Nirmaya is ineligible to participate in any of the tenders floated by Kerala Medical Services Corporation for next three years.
According to sources from the corporation , the company was unable to execute the purchase orders because of unprecedented industrial relations at their factory and the company managers could not bring back normalcy at the factory and regularize the supply.
Sources from the Corporation said Medipol Pharmaceuticals and Agron Remedies have been blacklisted due to the non-compliance of GMPs under Drugs and Cosmetics Act 1940 and Schedule M of Drugs and Cosmetics Rules 1945. According to them, Medipol has supplied one kind of drug (Metaprolol Tab 50 mg) in the outer cover of another drug (Propranolol Tab 20 mg) printed with the same batch number, manufacturing date and expiry date. They said it was a deviation from the compliance of good manufacturing practices and Schedule M of the D&C Rules. Amoxicillin dry syrup 125 mg (batch No.DMX018) supplied by the company has developed colour change during storage . The quantity in some of the bottles was less than the claimed quantity and some bottles were empty. These factors were also reasons for the termination of agreements, they said.
Whereas, in the supply to the District Drug Warehouse of the Corporation at Kannur, Agron Remedies has packed one unit of cetrizine hydrochloride 10 mg Tab (100 tablets) in the box of Tab amlodipine I.P. 2.5 mg printed with the same batch number, manufacturing date and expiry date. Office of the KMSC Ltd has informed Pharmabiz that five strips of the products were supplied without printing the batch number, manufacturing date and expiry date.
The Corporation has found that apart from the violations of provisions of Drugs and Cosmetics Act and Rules , it is a failure of the Quality Assurance System adopted by the companies for all the lapses. The managing director said if proper systems under the Act and Rules were followed the supply of the finished products could be correctly processed. The Corporation has disqualified and blacklisted the three companies in the tender processes of the Corporation for next three years.
The Corporation has also wanted Agron Remedies to take back the existing stock of all the 6 items of drugs already supplied by them during the tender period at their own cost within one month of the issue of the termination letter.
Meanwhile, Medipol Pharmaceuticals has approached the High Court of Kerala against the decision of the KMSC Ltd, it is learnt.