Painkillers, fertility drugs: Centre bans production of 35 combination drugs
What's the story
India's top health regulator, the Central Drugs Standard Control Organisation (CDSCO), has sent out an urgent notice to all states and Union Territories.
It has asked them to stop the manufacturing, sale, and distribution of 35 unapproved fixed-dose combination (FDC) drugs, News18 reported.
The list includes painkillers, anti-diabetics, hypertension drugs, and neuropathic pain relievers, as well as fertility drugs and nutritional supplements.
Drug safety
CDSCO's letter highlights risks of unapproved FDCs
The Drug Controller General of India (DCGI), who heads the CDSCO, has notified all state and UT drug controllers about the manufacture and sale of "unapproved FDCs."
He enclosed a list of 35 such medicines that had been earlier approved by state authorities without a safety and efficacy review by the CDSCO.
Their licenses were subsequently revoked or withdrawn voluntarily after show-cause notices over patient safety.
Regulatory oversight
CDSCO's action follows discovery of improper approvals
News18 report stated that CDSCO took the step after it found that several FDC drugs were cleared without adequate safety and efficacy checks.
The DCGI noted the urgent and serious nature of the issue, saying, "This poses a serious risk to public health and safety."
He urged state and UT drug regulators to look into these unapproved FDCs and take necessary action.
Regulatory discrepancies
Discrepancies in approval processes led to confusion
The confusion around these unapproved FDCs happened because of different approval processes in various states.
Companies contended they hadn't violated any laws, since they had a proper license from state authorities.
Upon issuing show-cause notices to the manufacturers, pharma companies stated that "these licenses were granted by the respective Drug Licensing Authorities...This has resulted in a lack of uniform enforcement of the provision of NDCT Rules 2019 under the Drugs & Cosmetics Act 1940 across the country."
Regulatory compliance
DCGI instructs uniform enforcement of drug approval rules
In the letter to drug controllers of all states and UTs, the DCGI has directed them to re-examine their approval process for FDCs.
He urged them to "review their approval process for such FDCs and ensure strict compliance with the provisions of the Act and Rules."
Last year, the government had also banned 156 fixed-dose combination medicines, including antibiotics used for fever and colds, painkillers, and multivitamins, saying they are "likely to involve risk to human beings."