The Union ministry of health and family welfare has proposed immediately suspending licences of those drug manufacturers whose products were classified as “not of standard quality” (NSQ) after failing to meet certain specified parameters.
The proposed amendment envisions immediate suspension of the manufacturing licence upon receipt of a government analyst’s report declaring the drug as NSQ with respect to assay, dissolution, related substances, impurities or sterility. Under existing provisions, suspension or cancellation of a manufacturing licence is preceded by the prescribed regulatory procedure, including issuance of a show-cause notice. This may result in a gap between the declaration of a drug as NSQ and initiation of regulatory action, during which the drug may remain in circulation, posing potential public health risks and making effective recall more difficult. Under the proposed mechanism, the analyst’s report would be endorsed to the Drugs Controller General of India, the State/UT licensing authority concerned under whose jurisdiction the manufacturing site is located, as well as the manufacturer and marketer of the drug concerned.
The statement added that key amendments have also been proposed to Form 13, relating to the test report of the government analyst.
“The proposed amendments seek to enable prompt regulatory intervention upon detection of substandard medicines, prevent their continued manufacture and distribution, and strengthen the mechanism for ensuring compliance with prescribed quality standards, in the interest of patient safety and public health,” the statement said. “These parameters are critical to determining the quality of medicines,” said the statement. “The proposed arrangement is aimed at ensuring timely communication of NSQ findings to the relevant authorities and stakeholders, thereby facilitating coordinated regulatory action and strengthening accountability across the drug manufacturing and marketing chain,” it said.
