Union Minister Jitendra Singh inaugurated a new biotechnology facility and dedicated a national facility for recombinant cells and sensors at the Rajiv Gandhi Centre for Biotechnology in Thiruvananthapuram, highlighting India's focus on biotechnology and its potential for economic growth.
United States Senator Jim Banks has urged the Food and Drug Administration (FDA) to step up inspections of overseas pharmaceutical manufacturing facilities, expressing concern over poor-quality drugs being imported from countries like India and China.
The Enforcement Directorate (ED) raided premises linked to Sresan Pharmaceuticals, the manufacturer of Coldrif cough syrup linked to the deaths of children in Madhya Pradesh and Rajasthan, and top officials of the Tamil Nadu FDA as part of a money laundering investigation.
Health ministry advisory urges rational use of cough syrups in children after 11 deaths in Madhya Pradesh and Rajasthan.
The Centre is considering a proposal on increasing coverage under the Ayushman Bharat scheme to Rs 10 lakh from the current Rs 5 lakh.
Rise in raids on illicit drug manufacturing units, alongside arrests for the production, sale, or distribution of spurious or adulterated drugs.
Most of the pharma units are failing in documentation, and validation processes, and many don't have full-fledged quality control laboratories.
With an eye on improving quality assurance in the wake of increased global scrutiny on Indian pharma products, the Centre on Tuesday said that Schedule M of the Drugs and Cosmetics Act, 1940 will be made compulsory for small and medium scale manufacturers in a phased manner. Union Health Minister Mansukh Mandaviya has asked micro-small and medium enterprises in pharma manufacturing to move towards good manufacturing practices (GMP) through self regulation. "This will help in quality assurance and also reduce compliance burden," Mandaviya.
A notification of the revised Schedule M rules by the Ministry of Health and Family Welfare has elicited mixed responses from the pharma sector and industry observers. While the industry has welcomed the revision of rules, several analysts said that implementation and compliance can become a challenge for smaller pharmaceutical companies. The Schedule M of the Drugs and Cosmetics Rules specifies the good manufacturing practices (GMPs), which aim to ensure quality of drugs made in the country.
Given the gap between budgetary allocation and use, a parliamentary standing committee has asked the Ministry of Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homeopathy (Ayush) to take steps to prevent underutilisation of funds under the National Ayush Mission (NAM) scheme. According to the data, the ministry was allocated Rs 1,200 crore for the mission in the Budgetary Estimate (BE) for FY24. The Revised Estimate (RE) for the year fell to Rs 815 crore, of which Rs 589 crore, or 74 per cent, has been spent till January.
In a major crackdown against the manufacture of substandard drugs, central and state regulators conducted joint inspections at 76 pharma companies and cancelled the licences of 18 of them for producing spurious and adulterated drugs, official sources said on Tuesday.
Rathod said the Maharashtra government had initiated an inquiry against 84 out of 108 manufacturers of cough syrups in the state.
Sun Pharmaceutical Industries Ltd on Thursday said its Halol facility in Gujarat has been listed under import alert by the USFDA with products manufactured at the unit now are subject to refusal of admission in the US market. The development follows an inspection of the facility by the US Food and Drug Administration (USFDA) from April 26 to May 9, 2022. "We now wish to inform you that the company has received a communication from the USFDA stating that the facility has been listed under Import Alert," Sun Pharma said in a regulatory filing.
The joint inspections is to ensure the safety, efficacy, and quality of drugs available in the country
Reacting to it, the vaccine maker said it is working towards resolving the issues cited during the inspection and the order of 20 million doses from the Brazilian government is still active.
The US health regulator has pulled up drug major Sun Pharma for manufacturing lapses, including failure to follow appropriate written procedures designed to prevent microbiological contamination of drug products, at its Gujarat-based plant. In a warning letter, the US Food and Drug Administration (USFDA) pointed out various lapses at the Halol plant which produces finished pharmaceutical products. "This warning letter summarises significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals... Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated," the USFDA stated.
Nearly 50 million doses of Bharat Biotech's COVID-19 vaccine, Covaxin lying with the firm are set to expire early next year as there are no takers owing to poor demand, company sources said.
A statement issued by the WHO on Saturday said the suspension is in response to the outcomes of its post EUL (emergency use authorisation) inspection held between March 14-22, 2022 and the need to conduct process and facility upgrade to address recently identified GMP (good manufacturing practice) deficiencies.
In the letter, Somani said the samples of four made-in-India cough syrups linked to the deaths of 66 children in Gambia which were tested in government laboratory here were found to be complying with specifications and not to have been contaminated with DEG or EG according to the test reports.
Ankleshwar plant is the third such facility to face action
'The deaths of the children in the Gambia would batter India's reputation as the developing world's pharmacy.'
Adar Poonawalla said he was hopeful that Covovax, the Novavax vaccine made by SII, will be launched around October this year for adults and for children by the first quarter of next year, depending on DCGI approvals.
Indian drug firms like Marksans Pharma, Aurobindo Pharma, Zydus and Jubilant are recalling products in the US market, as per the latest enforcement report by the US Food and Drug Administration (USFDA). While Marksans Pharma is recalling diabetes drug, Zydus Pharmaceuticals (USA) is recalling drug which is used to reduce stomach acid. Similarly, Aurobindo Pharma (USA) is recalling pain relieving drug, while Jubilant Cadista is recalling a medication used to treat schizophrenia.
"We suspended the deal as a simple preventive measure, since there are complaints that could not be explained well by the complainant, so we opened a preliminary investigation last week," said Rosario, head of the Federal Comptroller General.
The company did not comply to the 'good manufacturing practice' norms.
Zydus plans to initiate the clinical trials of ZyCoV-D in July 2020 across multiple sites in India. In animal studies the vaccine was found to elicit a strong immune response in multiple animal species like mice, rats, guinea pigs and rabbits.
The generic drugs at issue were manufactured at Ranbaxy's facilities in Paonta Sahib and Dewas in India and included acne drug Sotret, epilepsy and nerve pain drug gabapentin and antibiotic ciprofloxacin.
In March, the FDA had issued an import alert, banning formulations and active pharmaceutical ingredients from the factory.
The US drug regulator raised the issue of significant deviations from the current good manufacturing practice (cGMP) in three of DRRD's plants in a letter issued in November 2015
All of Ranbaxy's India-based factories are currently banned by the FDA from exporting medicines to the United States, the company's largest market, after the regulator's inspection found violation of its so-called good manufacturing practices.
The US Food and Drug Administration (USFDA) has issued a warning letter to RPG Life Sciences for violation of current good manufacturing practice (CGMP) norms at its two plants at Ankleshwar and Mumbai.
Suit alleges fraud by hiding significant deficiencies in CGMP regulations enforced by US health regulator.
The NIH said results of two studies of blood serum from people who had received Covaxin suggest that the vaccine generates antibodies that effectively neutralise the B.1.1.7 (Alpha) and B.1.617 (Delta) variants of SARS-CoV-2, first identified in the United Kingdom and India, respectively.
The regulator has given the company 15 days to take corrective measures and report back to it.
While the US health regulator did not specify details for issuing the alert, it said 'detention without physical examination may be appropriate when an FDA inspection has revealed that a firm is not operating in conformity with current good manufacturing practices'.
'Almost 70 per cent production time of a vaccine is dedicated to quality control, which is done through several hundred tests.'
The letter mentions certain cGMP violation based on site inspections conducted between July and August 2009.
Earlier last month US FDA officials had seized drug products manufactured by Caraco Pharmaceutical at its Michigan facilities in Detroit, Farmington Hills, and Wixom, alleging violation in good manufacturing practice.
The rap from both the US and UK drug regulators, including the latest one from the latter, has hit the scrip.
The US Food and Drug Administration has tightened rules for selling dietary supplements in the US market, making compliance with current good manufacturing practices mandatory for manufacturers.
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