Even while the health ministry continues to push its case to restrict domestic suppliers of vital pregnancy drug oxytocin to Karnataka Antibiotics and Pharmaceuticals Ltd (KAPL), quality tests conducted by a state regulator recently paint an ominous picture—the public sector undertaking was flagged recently for a substandard batch of the very same injectible drug for which the government wants it to be the only manufacturer in the country.
The Karnataka Drugs Control Department on October 10, 2018 found a batch of oxytocin injection manufactured by KAPL to have failed quality tests, according to the drug alerts on its website.
KAPL was authorised to manufacture and market oxytocin injection for domestic use starting September 1, 2018, according to its website.
However, substandard oxytocin is not the only product that KAPL has been flagged for—between 2014 and 2019, at least 24 batches of other medicines, including painkillers like paracetamol and antibiotics like norfloxacin, produced by the PSU have been listed as being “not of standard quality” (NSQ) by this state regulator alone.
The Indian Express reported in November 2016 that Gujarat’s drug regulator had found that KAPL had manufactured a substandard batch of important stomach medication omeprazole, which failed tests to check the time the drug takes to dissolve into the blood stream.
Over the years, some medicines produced by KAPL have also failed tests by the Central Drugs Standard Control Organisation (CDSCO), India’s apex drug regulatory body. Between August 2014 and December 2018, CDSCO found 24 batches of KAPL’s drugs, including crucial diabetes medicine glimepiride and cholestrol drug atorvastatin, to be NSQ.
The PSU’s name also figured in a list of drug makers with over five NSQ drugs in a nationwide survey conducted during 2014-16 through the National Institute of Biologicals, for having 15 samples of drugs failing quality tests.
The centre in 2016 had also debarred KAPL from supplying 500 mg paracetamol tablets to various state and central government institutions until February 2019 following test reports—a move that KAPL dragged the health ministry and Directorate General of Health Services (DGHS) to the Karnataka High Court to challenge.
Some of these issues have been raised in court filings in an ongoing case by the health ministry at the Supreme Court to allow it to prevent private drug makers from producing and selling oxytocin in India.
“The Government has filed SLP in the Supreme Court challenging the order of the High Court and the matter is sub-judice,” stated the health ministry and CDSCO in response to The Indian Express’ queries about quality issues related to KAPL.
When a product is substandard, it is not effective in treating the ailment for which it is being consumed. Doctors say oxytocin is an essential drug used to prevent new mothers from bleeding to death during childbirth.
Between 2015 and 2018, CDSCO has also found 18 batches of oxytocin manufactured by private drug makers to have failed quality tests.
However, brands like Pitocin, Syntocinon and Evatocin, which capture the largest shares of their oxytocin markets, have not figured in the available drug alerts that The Indian Express reviewed.
Queries sent to KAPL on Wednesday about issues related to the quality of its medicines and how it planned to ensure the quality of oxytocin it produced remained unanswered by press time.
The government wants to restrict the manufacturing and supply of oxytocin to PSUs so that it could curb its misuse, such as using it to make dairy animals produce more milk. In June, the ministry had announced KAPL would be the sole supplier of the drug.
The ministry and CDSCO have approached the apex court after drug makers like Mylan and Neon Labs as well as patient activist group All India Drug Action Network (AIDAN) challenged the move at the Delhi High Court. The high court in December 2018 set aside the government’s notification for reasons like it lacking scientific basis.