THE CENTRAL Drugs Standard Control Organization (CDSCO) has flagged five batches of medicines manufactured by three government-controlled drug manufacturers — Bengal Chemicals and Pharmaceuticals Ltd (BCPL), Orissa Drugs and Chemicals Ltd (ODCL) and Hindustan Antibiotics Ltd (HAL) — for failing quality tests.
At the same time, BCPL and HAL have disputed the claim that the samples were sub-standard, with BCPL also planning to challenge CDSCO’s findings. The top drug regulatory authority has labelled these batches of drugs as “not of standard quality”.
BCPL and HAL are Central Public Sector Enterprises, while ODCL is a joint venture between Indian Drugs and Pharmaceuticals, and Industrial Promotion and Investment Corporation of Odisha. As per the regulator’s findings, samples belonging to two batches of paracetamol manufactured by BCPL failed “dissolution” tests, which measures the rate at which the product would release the active ingredients needed to treat the body. A batch of albendazole (for worm infection), produced by ODCL, was also flagged for failing the dissolution test. A batch of ciprofloxacin (antibiotic) and a batch of sodium lactate solution (electrolyte replenisher), manufactured by HAL, have been marked as sub-standard.
BCPL has said that re-tests of the samples showed that they passed the quality tests. However, the PSE has withdrawn a batch of around 1.94 lakh tablets of paracetamol.
“After receiving the failed report (from CDSCO), we have again tested from representative ‘control sample’ and ‘sample sent by drug inspector’, and also got control sample tested from an external NABL-certified laboratory (ITL Labs). All the samples passed all the required tests, including the dissolution test…,” said Manotosh Bandyopadhyay, assistant general manager (quality assurance), BCPL. “We are going to challenge the report of the government analyst as per provision of the drug rules. But we have already recalled the batch as the government analyst declared it ‘not of standard quality’,” he told The Indian Express.
HAL also denied that its products are substandard, and said the regulator did not inform it that batches of its products had failed quality tests. “CDSCO have never informed HAL about the failure of Compound Sodium Lactate Injection IP 500 ml,” said HAL company secretary Ashok B Gawari. He said HAL received the information from ESI Hospital in Chennai instead.
HAL tested reference sample of the product from that batch and found it to conform to the Indian Pharmacopoeia, said Gawari, adding that this information was relayed to the regulator on November 23.
“We have not received any NSQ (not standard quality) finding about Ciprofloxacin IP 500 mg tablets from CDSCO,” he said. There is “no failure of quality of HAL product… It appears that the product was not properly stored at the customers’ place, which may have resulted in failure during testing,” said Gawari. HAL has “stringent” quality control measures and a standard operating procedure, he said. ODCL did not respond to questions sent by email on the failed tests.