Apex Drugs Regulatory Body CDSCO has directed drug controllers from all states and center areas, which include the manufacture, sale and distribution of 35 unpublished fixed-khurak combination drugs including painkillers, nutritional doses and anti-diabetes.

They have also been asked to review their approval procedure for such a fixed-khurak combination drugs (FDCs) and ensure strict compliance with the provisions of medicines and cosmetics act 1940 and rules.

FDC drugs are those in which a certain proportion combines two or more active pharmaceutical material (API).

The regulator issued instructions that it was revealed that some FDC drugs have been licensed for construction, sales and distribution without prior evaluation of security and efficacy, which led to a serious risk for public health and safety.

In a communication sent on 11 April, Drugs Controller General of India (DCGI) Dr. Rajiv Raghuvanshi mentioned a letter issued by his office in January 2013, where concerns raised concerns about the grant of manufacturing license for the sale of FDC drugs, which are without approval from DCGI under the definition of “new drug” in the country.

The same concern has been expressed from time to time and several letters have been issued to the concerned state licensing officers who have allowed for manufacturing and marketing of unpublished FDCs. The most recent letter of this year was released in February this year.

“It has come in the notice of the Directorate that some FDC drugs have been licensed for construction, sales and distribution without prior evaluation of security and efficacy as per the provision of NDCT Rules 2019 under Drugs and Cosmetics Act 1940. It is a serious risk for public health and safety,” a letter said.

Such unpublished FDC approval compromises the safety of the patient and the absence of scientific verification can lead to adverse drug response, drug interaction and other health hazards, underlining the letter.

On issuing a show-causal notice to the manufacturers, he has said that these licenses were provided by the concerned drug licensing officers and not violated any rules.

As a result, under the Drugs and Cosmetics Act 1940 across the country, there has been a shortage of enforcement as the provision of NDCT Rules 2019, it has been reported in the letter.

The letter stated that the above, all state and center area drug controllers are requested to review their approval process for such FDCs and to ensure strict compliance with the provisions of the Act and rules.

The letter also listed 35 unpounted FDCs, earlier licenses for construction, sales and distribution by the state/ UT drug controllers, which have been presented by the Central Drug Standards Organization (CDSCO) without the evaluation of security and efficacy and later by the drug licensing officers (SLAS) or voluntarily presented by those responsible for reference.