Govt drawing up parameters to gauge states for drug enforcement, improve quality of products
1 month, 2 weeks ago

Govt drawing up parameters to gauge states for drug enforcement, improve quality of products

Live Mint  

New Delhi: The Union government is drawing up an index to gauge states and union territories on their preparedness to enforce Central regulations on drugs, medical devices and cosmetics, according to officials and documents. Therefore, there is work in plan to bring a Drug Regulatory Index for the State/UTs to get uniformity in enforcement practice," one of the officials said. “In order to ensure the effective regulation of medical product including drugs, medical devices and cosmetics, it is proposed to create a State Drug Regulatory Index to improve the standards of drug regulation across the country and enhance its global standing. The primary objective of the State Drug Regulatory Index is to enhance the effectiveness and uniformity of drug regulatory mechanisms across the country by strengthening drug safety surveillance, promoting accountability, fostering collaboration, enhancing resource utilization," stated the minutes of the meeting.

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History of this topic

DCGI seeks post-market surveillance data on 2 combination drugs within 3 months
3 weeks, 6 days ago

DCGI seeks post-market surveillance data on 2 combination drugs within 3 months

Live Mint  

Drugs Controller General of India has sought active post-market surveillance data from the drugmakers of two fixed-dose combination medicines—Imipramine Hydrochloride IP + Diazepam IP tablets used to ease co-morbid anxiety conditions, and Chlorphenamine Maleate IP + Ammonia Chloride IP + Sodium Citrate IP syrup used to relieve cough and respiratory distress. “Manufacturers who are already holding licences from State Licensing …

Himachal govt to set up STF to combat drug abuse, crime: CM
2 months, 1 week ago

Himachal govt to set up STF to combat drug abuse, crime: CM

Hindustan Times  

letterschd@hindustantimes.com Himachal Pradesh chief minister Sukhvinder Singh Sukhu said, “The STF will be equipped with a dedicated commando force, with personnel undergoing specialised training on anti-narcotics and organized crime in collaboration with the Narcotics Control Bureau.” Himachal Pradesh chief minister Sukhvinder Singh Sukhu on Wednesday directed the state government to set up a special task force to combat drug abuse …

Apex drug regulator to more than double staff strength with 250 new positions in effort to help enforce quality norms
4 months, 2 weeks ago

Apex drug regulator to more than double staff strength with 250 new positions in effort to help enforce quality norms

Live Mint  

New Delhi: The government plans to more than double staffing at the Central Drugs Standard Control Organization by filling 250 new positions to strengthen enforcement of good manufacturing practices for medicines, vaccines and medical devices, two people aware of the development said. In addition, an additional drugs controller will be appointed for the first time at the country’s apex drug …

Govt plans common drugs standards for all state regulators
2 years ago

Govt plans common drugs standards for all state regulators

Hindustan Times  

The Union health ministry is considering formulating common standards for drug regulators at the Centre and the states and maintaining a central database to better regulate the manufacturing, sale, and distribution of drugs, according to people familiar with the matter -- a move likely triggered by recent deaths globally that were linked to consumption of drugs manufactured in India. Once …

Book Review: ‘The Truth Pill: The Myth of Drug Regulation in India’ by Dinesh S. Thakur and Prashant Reddy T.
2 years, 1 month ago

Book Review: ‘The Truth Pill: The Myth of Drug Regulation in India’ by Dinesh S. Thakur and Prashant Reddy T.

The Hindu  

Published : Jan 26, 2023 10:25 IST Truth, they say, is a bitter pill to swallow. The Truth Pill by Dinesh S. Thakur and Prashant Reddy is replete with bitter truths about India’s drug regulatory architecture, which calls for some soul-searching by policymakers. The authors argue that the manufacturing and the quality of life-saving drugs and medicines are an issue …

Centre rushes to defend Indian pharma firms
11 years, 9 months ago

Centre rushes to defend Indian pharma firms

The Hindu  

The government, on Monday, said the quality of drugs produced by the pharma industry was of proven global standards and the sector was a highly regulated one. “The pharmaceutical sector is a highly regulated one, and the exports are heavily guided by various regulatory regimes of the importing countries.,” the Commerce and Industry Ministry said in a statement. The government’s …

Panel exposes flaws in India’s drug approval procedure
12 years, 10 months ago

Panel exposes flaws in India’s drug approval procedure

Live Mint  

New Delhi: A report by a parliamentary committee has shown that the drug industry regulator, the Drug Controller General of India, has been approving, on average, one new drug a month without conducting mandatory clinical trials or seeking expert medical opinion—findings that expose the deep flaws prevalent in India’s drug approval process. According to the committee’s findings, CDSCO approved 33 …

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