Health Ministry moots Centre or state bodies be empowered to regulate drugs, cosmetics manufacture
1 year, 5 months ago

Health Ministry moots Centre or state bodies be empowered to regulate drugs, cosmetics manufacture

Firstpost  

The draft New Drugs, Medical Devices and Cosmetics Bill, 2023, has a separate chapter on AYUSH medicines, proposing for the first time to regulate Sowa Rigpa and homoeopathy. The latest draft of the New Drugs, Medical Devices and Cosmetics Bill, 2023, which seeks to replace the Drugs and Cosmetics Act of 1940, is yet to be approved by the Cabinet. “Notwithstanding, anything contained in this Act, the Central Licensing Authority or the Central Drugs, Medical Devices and Cosmetics Regulatory Authority may in public interest, abbreviate, defer or waive such pre-clinical and clinical data requirements for approval of new drug or clinical trials of new drug, investigational new drug or approval of medical device or clinical investigation of investigational medical device… taking into account its severity, rarity, un-met medical need, emergency, extreme urgency,” the draft bill read. The draft New Drugs, Medical Devices and Cosmetics Bill was placed in the public domain last year, seeking feedback from stakeholders.

Medical Drugs Medical Devices Trials Clinical Trials State Centre Drug Devices Bill Draft Health Ministry Regulate Clinical Cosmetics New Drugs Medical Device Cosmetics Bill Medical Devices And  empowered  health  regulate  draft  centre  manufacture  devices  trials  moots  clinical  drugs  central  bill  cosmetics  medical  ministry  drug  state

History of this topic

Medical device industry asks Health Ministry to reconsider new regulatory Bill
1 year, 5 months ago

Medical device industry asks Health Ministry to reconsider new regulatory Bill

The Hindu  

An industry body for medical device manufacturers is opposing the Centre’s plan to bring the New Drugs, Medical Devices and Cosmetics Bill, 2022 to Parliament in the upcoming monsoon session, and has written to Health Minister Mansukh Mandaviya, expressing its dismay. ‘Entirely different products’ The Association said that it was also strange that the Parliamentary Committee’s 138th report, released on …

Budget session: Centre seeks to regulate online pharmacies through revised bill
1 year, 10 months ago

Budget session: Centre seeks to regulate online pharmacies through revised bill

Hindustan Times  

The central government has proposed to regulate online pharmacies, which has proliferated in recent times in India, through a fresh draft of the New Drugs, Medical Devices, and Cosmetics Bill, which has been released for discussions, according to people familiar with the matter. The government may regulate, restrict or prohibit the sell, stocking, exhibiting or offer for sale or distribution …

Need For Improving Pharmaceutical Laws - The Proposed Way Forward
2 years, 3 months ago

Need For Improving Pharmaceutical Laws - The Proposed Way Forward

Live Law  

With the rising need to accommodate the new requirements and adaptation of modern technology in the pharmaceutical sector, the draft of the 'Drugs, Medical Devices and Cosmetics Bill, 2022' has been released by the Ministry of Health and Family Welfare on July 8, 2022, which seeks to replace the existing archaic law under the Drugs and Cosmetics Act of 1940 …

Health Regulator geared up for smooth transition to licensing of Class A and B Medical Devices
2 years, 4 months ago

Health Regulator geared up for smooth transition to licensing of Class A and B Medical Devices

The Hindu  

The reconstituted National Medical Device Promotion Council under the Department of Pharmaceuticals, in its first meeting held on Wednesday was updated on the steps taken up by Central Drugs Standards and Control Organisation and the State Licensing Authorities for the smooth transition to licensing of Class A and B Medical Devices w.e.f 1st October 2022. Another important issue deliberated in …

The many infirmities of drugs and medical devices bill
2 years, 5 months ago

The many infirmities of drugs and medical devices bill

Live Mint  

The new Drugs, Medical Devices and Cosmetics Bill 2022—proposed replacement for the pre-Independence Drugs and Cosmetics Act 1940—is a step forward in making the law more contemporary but still falls short of what is required. Recognising medical devices as a separate category in its own right is welcome—till now, it has been regulated on par with drugs, vetted by the …

Draft Bill seeks to regulate online pharmacies, clinical trials and medical devices
2 years, 6 months ago

Draft Bill seeks to regulate online pharmacies, clinical trials and medical devices

The Hindu  

The recently-released draft of the New Drugs, Medical Devices and Cosmetics Bill, 2022, by the Union Ministry of Health and Family Welfare has proposed to regulate e-pharmacies, clinical trials and medical devices among others. The draft includes provisions for penalties, including imprisonment, for failing to pay compensation for injury or death during clinical trials for both drugs and medical devices. …

Panel Formed by Modi Govt to Frame New Law for Drugs, Cosmetics Given Extension Till Feb to Pen Draft
3 years ago

Panel Formed by Modi Govt to Frame New Law for Drugs, Cosmetics Given Extension Till Feb to Pen Draft

News 18  

The Narendra Modi government-constituted panel to frame new laws for medicines, cosmetics and medical devices has been given an extension of three months to submit the draft document, News18.com has learnt. “The request for extension was made by Drug Controller General of India VG Somani last month considering that writing the draft with clarity is of utmost importance.” The present …

EXCLUSIVE I Modi Govt Sets Up Panel to Frame New Laws for Medicines, Cosmetics, Medical Devices
3 years, 4 months ago

EXCLUSIVE I Modi Govt Sets Up Panel to Frame New Laws for Medicines, Cosmetics, Medical Devices

News 18  

The Narendra Modi government has formed a panel to frame new laws for medicines, cosmetics and medical devices, News18.com has learnt. According to the internal order, accessed by News18.com, “The government has decided to constitute a committee for framing/preparation of New Drugs, Cosmetics and Medical Devices Bill so that New Drugs, Cosmetics and Medical Devices Act can be framed.” The …

Govt releases guidelines for schemes to boost domestic manufacturing of bulk drugs, med devices
4 years, 5 months ago

Govt releases guidelines for schemes to boost domestic manufacturing of bulk drugs, med devices

India TV News  

The government on Monday released guidelines of four schemes for the development of bulk drug and medical device parks in the country to promote their domestic manufacturing. "In line with the vision of Prime Minister Shri Narendra Modi, the schemes have been conceptualised for making India ''Atma Nirbhar'' in the pharma sector," Union Minister of Chemicals and Fertilisers D V …

How govt's new rules on drug retailing will make your life safer and better
5 years, 2 months ago

How govt's new rules on drug retailing will make your life safer and better

Business Standard  

The government plans to soon make commonly used drugs available at local retail outlets, with their labelling containing important information — preferred dosage and side effects — in local languages. A new schedule is likely to be created under the Drugs and Cosmetics Act for OTC formulations so that these commonly-used medicines, which are not ‘prescription only’ and are relatively …

New rules mooted on drugs dispensed by doctors
5 years, 6 months ago

New rules mooted on drugs dispensed by doctors

The Hindu  

The Central Government is considering amendments to the Drugs and Cosmetic Rules, 1945 to ensure that registered medical practitioners dispense only generic medicines. “A proposal was received by the CDSCO committee wherein the DCC was apprised that registered medical practitioners can supply different categories of medicines including vaccines to their patients under the exemption provided, with certain conditions, under Schedule …

Discover Related