Hospitals dealing in radiopharma products to comply with all provisions in Act: Govt

Vexed over the noncompliance of Drugs & Cosmetics Act 1940 while importing radiopharmaceutical diagnostic products, the Centre has issued notices to several hospitals across the country, asking them to immediately fulfil all provisions under the Act.

Radiopharmaceutical and radioimmunoassay diagnostic products for therapeutic and diagnostic use are required in hospitals for the treatment of cancer and many other diseases. These products are regulated under the provisions of Drugs & Cosmetics Act 1940 and Rules, 1945.

Concerned over the ignorance at the end of importers, the Central Drugs Standard Control Organisation (CDSCO) under the Ministry of Health and Family Welfare convened a meeting in November 2016 with stakeholders along with experts to discuss the issues related to regulations for import of radiopharmaceutical products.

"We gave importers a transition time of 45 days to fulfil the requirements under the Drugs and Cosmetic Act that has already expired on 21 December 2016. We have directed the importers to obtain necessary permission under the provisions of the Drugs and Cosmetics Act 1940 & Rules made," said Dr G N Singh, Drug Controller General of India (DCGI).

"It has been decided in consultation with the Ministry of Health and Family Welfare that no concession can be given in respect of regulatory requirements under the Drugs and Cosmetics Rules after this point of time. We have already issued notices to all the hospitals for strict compliance. Indigenous products will soon be getting the things in place, though imported products seem to take some more time," he said.

Bhabha Atomic Research Centre (BARC) – an apex body that oversees and approves all radiation related projects in India. The DCGI refers all clinical trials that involve the use of radiopharmaceuticals to BARC for its expert opinion. In parallel, the Atomic Energy Regulatory Board (AERB) issues No Objection Certificates (NOC) to the Institutes o and hospitals to import and receive radiopharmaceuticals.

"For a long time the hospitals were complying with the provisions under the Act. We only look at the regulatory part of radiopharmaceuticals products. This cannot be tolerated when we want to provide world class facilities to our patients. There should not be any lag in procuring any imported product that comes under CDSCO," said Dr Singh.

Radiopharmaceuticals are drug formulations which are used in nuclear medicine for diagnosis and therapy for various diseases and at various stages of treatment. These drug formulations contain radioactive isotopes and are already used in many developed countries.