Following Central Drugs Standard Control Organization (CDSCO) order offering transition time of 45 days to importers of radiopharmaceutical and radio immunoassay products which ended on December 21, 2016, the Central drug regulator has directed to all concerned hospitals and importers that no further request for time concession will be entertained to fulfill the regulatory requirements under the provisions of Drugs and Cosmetics Rules, 1945.
All the hospitals and importers dealing in radiopharmaceuticals were required to obtain necessary permission and register them for the radiopharmaceutical products to be made available to cancer and other patients in the hospitals before their expiry.
Atomic Energy Regulatory Board (AERB) issues NOC to the institutes or hospitals to import or receive radiopharmaceuticals.
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.
Radiopharmaceutical and radio immunoassay products for therapeutic and diagnostic use are regulated under the Drugs and Cosmetics Act, 1940 and Rules 1945.
Following the meeting of stakeholders with experts at CDSCO headquarters recently to discuss issues related to import of such products, transition time was given to the importers to fulfill the requirements which got expired on December 21, 2016.
Says Drug Controller General of India Dr G N Singh, “All the major radiopharmaceutical importers and hospitals have fulfilled the regulatory requirements and uploaded their documents towards compliance. Respecting the timelines approved in consultation with the Union health ministry, we at the same time are also open to consider any issue related to compliance based on suitable explanations from the concerned importer or institution to address the grievances in the public or patient interest.”
The Government had also formed a committee two years ago under Department of Atomic Energy (DAE) to provide radioactive source (Cobalt-60) to around 240 odd cancer hospitals free of cost. This is a part of Government's policy for enhancing radiotherapy facilities for cancer treatment.
Board of Radiation Isotope and Technology (BRIT), which is a unit of the DAE headquartered in Navi Mumbai, has been entrusted with the job to supply these sources to the hospitals at a nominal cost of Rs 50 lac based on their demands in accordance to the regulatory guidelines of AERB. Regulatory requirements include authorisation from AERB, presence of a radiology safety officer with the hospital and details of the grant made. According to sources, first batch of the radioisotope (Cobalt-60) is available with BRIT.
As per official sources, cancer hospitals can get grants if they approach the apex committee of DAE for purchase of radioactive source which can be made available through indigenously manufacturing them. Earlier the radioactive sources were being imported from Canada and Russia and hence were capital intensive. The recurring radioactive source (Cobalt-60) used to cost about one crore which could be used for 10 years.
Considering the fact that over 4 million cancer patients in India are in need of cancer treatment, Government's plans to provide the radioactive source in existing tele-cobalt based radiation equipment spread across cancer hospitals in the country would be a boon.
India as of today has 550 odd radiation units out of which tele-cobalt based equipment account for 50 per cent of the infrastructure.