Panel recommends renaming India’s drug regulator for better international visibility
A high-level committee has recommended renaming India’s drug regulatory authority to give it national and international visibility.
The present nomenclature of Central Drugs Standard Control Organisation (CDSCO) does not reflect the “true and extended functional character of the organisation” that regulates cosmetics, medical devices, diagnostics kits, blood banks, other than setting standards of drugs and regulation of imports, the panel said in its report.
It has proposed three options — Central Medical Products Administration, India (CMPA), Central Medical Products Regulatory Agency, India (CMPRA), and National Medical Products Regulatory Agency, India (NMPRA) — to rename the agency.
It would be possible to rename CDSCO with an executive order by the government since the nomenclature is not mentioned under the Drugs and Cosmetics Act, 1940, the panel said.
It has also suggested that the organisation should be headed by a Medical Products Controller General of India, which should be at the level of additional secretary. At present the post of Drug Controller General (India) is equivalent to the level of joint secretary.
“The changes are required to enhance the visibility and stature of the organisation at a global level,” the committee said in its report ET has seen a copy of the report. The panel has also recommended bringing ayurveda, yoga & naturopathy, unani, siddha and homoeopathy (Ayush) and medical devices under the ambit of the new organisation.
It has recommended five verticals — new drugs, cosmetics and clinical trials; biologicals; AYUSH; medical devices; and legal, enforcement and investigation. Each level should be headed by a controller at the level of joint secretary with decision-making powers for disposal of all technical matters, it said. There should also be a separate cadre for medical devices vertical. The committee has also recommended replacing the archaic 1940 Drugs and Cosmetics Act with a new Drugs and Cosmetics and Medical Devices Act.
The government plans a major overhaul of the country’s drug regulatory authority in a bid to bring changes in line with global standards and to deliver services efficiently.
The committee has suggested a slew of measures to reduce the number of regulatory steps and time taken for approvals, to fast track introduction of new drugs in the country, and facilitate coordination between multidisciplinary institutions such as Indian Institute of Science and IITs for promoting innovation in new devices and diagnostic kits. Drug discovery and research in institutes are largely limited to academic purposes rather than translational research, it said.
There is a gap in the ecosystem in respect of research capability, skill, and use of technology, among others as compared to regulatory authorities of other countries like USFDA, TGA (Australia), MHRA (UK), and PMDA (Japan).
“Approvals granted by these authorities are accepted globally,” the report said.
In 2017, top drugs advisory body Drugs Technical Advisory Board (DTAB), too, had recommended renaming CDSCO.
The committee said the regulatory reforms are essential to build image of Indian drug regulators and also “to make a transparent, reliable, fool proof drug regulatory system in India in order to ensure reliance on our regulatory system by other countries. This would enable us to minimise the inspections of Indian companies by outside agencies and at the same time gain international confidence on our system,” the committee opined.
It has also recommended amendment to the Drugs and Cosmetics Act to incorporate clinical trials, approval of new drugs, procedure for import and export on the lines of allopathic drugs.
The committee has said that at present the organisation lacks monitoring of adverse events. There are inadequate testing laboratories, manpower, and training to regulators. There are no offices of CDSCO in foreign countries from where major import occurs. “There is also a problem of over concentration on pre market rather than post market monitoring,” it said.
The committee has suggested strengthening of infrastructure by opening zonal and sub zonal offices of CDSCO in all major states.
To reduce delays and inefficiency disposal of files, it has recommended that the present system of sending it to the Directorate General of Health Services (DGHS) and then to the drug division of the health ministry should be changed. “In order to expedite the decision making the CDSCO filed be sent to the ministry of health which may consider taking technical inputs on case to case basis, if required from the DGHS,” it said.
Earlier Prime Minister Narendra Modi had raised concerns over the ability of the regulatory framework to keep with the industry and scientists. Tasked to reform the drug regulatory system of India a committee was then formed by the cabinet secretary in May this year.
Source : economictimes