India’s top drug regulatory authority has flagged 18 batches of medicines, including Piramal Enterprises’ multivitamin brand ‘Supradyn’ and a painkiller manufactured by public sector undertaking (PSU) Karnataka Antibiotics and Pharmaceuticals Ltd (KAPL), for failing quality tests conducted last month.
The Central Drugs Standard Control Organisation (CDSCO) this month labelled these batches as “not of standard quality” for failing tests conducted in July to prove the purity of their ingredients.
Piramal Enterprises, which markets Supradyn here, said it has not received any communication from CDSCO about this and that its products are released in the market “only after they have complied to all required specifications as per the Drugs and Cosmetics Act, and conform through their shelf life”.
Emails sent to KAPL remained unanswered by press time Wednesday.
CDSCO found at least one batch of Supradyn to have failed ‘assay’ tests to analyse the ingredient cyanocobalamin, which means there were less quantities of the ingredient than required in the approved combination. Cyanocobalamin is used to prevent and treat low levels of vitamin B12. The samples tested were from batch number MH3080, according to CDSCO’s drug alert.
It is not clear how many strips of Supradyn, which has 15 tablets in each strip, are to be recalled as part of this batch. “With reference to the mention of Supradyn in the list of drugs uploaded on the CDSCO website, we would like to state that Piramal Enterprises Limited has not received any communication from CDSCO on Supradyn failing quality tests, or as per your query, specifically due to assay of cyanocobalamin,” a Piramal Group spokesperson told The Indian Express.
The regulator also flagged at least three batches —1511917, 1508318 and 1512117 — of KAPL’s 50mg variation of diclofenac sodium, a non-steroidal anti-inflammatory (NSAID) painkiller, for failing “disintegration” and “related substances” tests.
Disintegration tests are conducted to see how effectively a medicine breaks down into fragments or granules in order to improve their solubility, and is the first step towards making the drug ready for absorption into the patient’s bloodstream. Tests for related substances are done to check for impurities and contaminants in the medicine that exist either from the process of manufacturing it or due to chemical changes from the medicine degrading, or breaking down, over time.
As on July 2019, Supradyn was the fourth largest multivitamin brand in its category, capturing 4.43 per cent of the Rs 1,433.50 crore market, according to data from pharmaceutical market research firm AIOCD PharmaTrac. However, its market share has dropped from 5.46 per cent in July 2018, according to the data. The regulator’s latest alert lists a total of 18 batches of drugs, ranging from painkiller paracetamol to a batch of antibiotic ciprofloxacin.
However, PharmaTrac’s data shows the manufacturers of the batches of the other drugs found to be substandard do not contribute a significant share of the overall sales of these formulations in the Indian market.