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The Center has proposed to empower the country’s apex drug regulatory body, CDSCO, to regulate the manufacture of drugs or cosmetics, instead of state drug regulators as is the norm at present, according to a revised draft of a bill sent about him. inter-ministerial consultations.
However, the sale of drugs, cosmetics and medical devices will continue to be regulated by the respective state governments, according to the revised draft of the New Drugs, Medical Devices and Cosmetics Bill, 2023, which seeks to replace the Current Drugs and Cosmetics Act. from 1940.
Furthermore, the provision of taking permission to operate an e-pharmacy has been deleted and replaced by the words ‘the central government may regulate, restrict or prohibit the sale, stocking, display or offer for sale or distribution of any drug by means of line by notification. ‘, according to the draft bill, a copy of which has been accessed by PTI.
The draft New Drugs, Medical Devices and Cosmetics Bill was placed publicly in July last year, seeking feedback from stakeholders.
The Union health ministry and the Central Drug Standard Control Organization (CDSCO) received several comments from stakeholders on the draft bill, which was accordingly revised by the ministry and sent for inter-ministerial consultations.
During the ongoing consultations on the draft bill, government think tank NITI Aayog approved the newly introduced provision to give the CDSCO powers to issue manufacturing licenses for drugs and cosmetics instead of state regulators, saying it will ensures uniform and effective implementation of the law and suggests a massive shift towards resting all manufacturing duties with a central licensing authority.
Section 22(c) of the draft Bill states: “Manufacturing for sale or distribution, any drug or cosmetic, except under and in accordance with a license granted by the central licensing authority in such form as prescribed manner. “
Currently, all manufacturing activities related to drugs and cosmetics are regulated by the respective state governments through their drug control organizations. Once the Senate passes the proposed bill, all the powers of the state governments related to the regulation of drug and cosmetics manufacturing will go to the Center through the CDSCO, an official source explained.
Currently, almost every area in the country has state drug control offices to administer provisions related to the manufacture and sale of drugs and cosmetics.
In order to implement the provision and effectively regulate the manufacturing of new drugs and cosmetics by the CDSCO, it has to be strengthened accordingly in terms of infrastructure and manpower, the source said.
In addition, regulations for conducting clinical trials for new drugs and medical devices have been brought under the draft bill.
Currently, the conduct of clinical trials for new drugs and medical devices and the provisions for compensation for injury or death due to participation in clinical trials, medical management of trial participants, regulation of the ethics committee etc. governed by the New Drugs. and Clinical Trials Rules, 2019. Also, medical devices are treated as drugs and there is no separate definition for those.
The draft bill has a separate chapter on AYUSH drugs, which proposes to regulate Sowa Rigpa and Homeopathy for the first time. The present act regulates only Ayurveda, Unani and Siddha drugs and cosmetics.
The draft bill has introduced various definitions or provisions, such as bioequivalence study, bioavailability study, clinical trial, clinical investigation, regulatory authority, manufacturer, medical device, new drugs, over the counter (OTC) drugs, adulterated cosmetics etc., for greater clarity and operation and smooth operation, an official said.
The penalties for offenses related to the importation of drugs and cosmetics have been suitably enhanced in the draft bill, another official said.
The proposed bill provides for the regulation of clinical trials of new drugs, new investigational drugs, the ethics committee etc.
“However, in the interest of public health or the extreme urgency of drugs, the central government has the power to make provisions for the central licensing authority to waive the requirement to conduct a clinical trial for the manufacture or import of new drugs or new investigational drugs in the country ,” the draft bill read.
“If any participant is injured as a result of his participation in the clinical investigation, the person, the sponsor, the clinical research institution, any other organization or investigator permitted under sub-section (1) of section 116 shall provide medical control to that participant.” he said.
Currently, all these provisions are there in the rules but now, these have been proposed in the bill, said an official.
In the current rules, there is no provision to impose penalties, such as imprisonment, on the errant companies or people for failing to compensate those who participate in the clinical trials for drugs and medical devices.