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In a letter to health minister Harsh Vardhan, the Indian Pharmaceutical Alliance, an industry body representing leading pharma companies, including Sun Pharma, Lupin, Dr Reddy's Labs, Cadila Health and Glenmark, stressed the need for an out-of-court settlement with health activists fighting for the rights of clinical trial participants.
India's first indigenously developed quadrivalent Human Papilloma Virus (HPV) vaccine for the prevention of cervical cancer will be launched in a few months and made available to the people in an affordable price range of Rs 200-400, Serum Institute of India CEO Adar Poonawalla said on Thursday.
The remarks of the top court came on a bail plea of an accused who was arrested after opium was found in his fields and has served more than five years in jail.
He had taken charge as the 25th director general of the Indian Coast Guard on July 19 last year.
The Serum Institute of India (SII) had put in an application to the Drugs Controller General of India (DCGI) in October for grant of market authorisation of Covovax for restricted use in emergency situations.
The vaccine maker Bharat Biotech said in a statement that preliminary reviews indicated that the death was unrelated to Covaxin.
Acting swiftly on the controversy regarding illegal drug-coated stents, the Maharashtra Food and Drug Administration has asked all stent manufacturers and importers to get valid licenses within the next two months from the Drugs Controller General of
India's drug regulator Drugs Controller General of India has granted permission to Mumbai-based pharmaceutical company Cipla to import Moderna's COVID-19 vaccine for restricted emergency use in the country, official sources said on Tuesday.
'We seem to be in a situation where we can do little, and nothing needs to be done anyway.'
Ramdev's herbal medicine company Patanjali Ayurved has launched 'Coronil tablet and Swasari vati' medicines claiming they can cure the highly contagious disease within seven days.
'We need to prove to the world that quality vaccines and R&D are possible in India.'
Whistle-blower Dinesh Thakur will speak on Made-in-India drugs at an event in Washington.
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.
Once the UK drug regulator gives its approval to the Oxford vaccine, the expert committee on COVID-19 at the Central Drugs Standard Control Organisation (CDSCO) will hold its meeting and thoroughly review the safety and immunogenicity data from the clinical evaluations conducted abroad and in India before granting any emergency authorisation for the vaccine here, official sources said.
The Drugs Controller General of India (DCGI) has granted permission to the Serum Institute of India (SII) to manufacture the Sputnik COVID-19 vaccine in India for examination, test and analysis with certain conditions, official sources said.
Pharmaceutical companies that have failed to meet the deadline -- which expired on July 1 -- to comply with Schedule M of the Drugs & Cosmetics Act will find the going tough in the days ahead.
Venus Remedies has obtained permission from the Drug Controller General of India for conducting Phase III clinical trials of the new formulation developed by its research and development wing.
'Pfizer India has submitted an application on December 4 to the DCGI seeking emergency use authorization for its COVID-19 vaccine in India'
The Drug Controller General of India (DCGI) has sought clarification from pharma majors Dr Reddy's Laboratories and Mumbai-based Piramal Healthcare, for allegedly sponsoring doctors for conferences.
PharmEasy, 1mg and Netmeds believe that their disruptive capabilities will power their brands despite the recent court ruling. The Drug Controller General of India recently directed all state FDAs to stop the online sale of medicines as per a Delhi high court order of last year.
The central drug regulator has issued show cause notices to these two importers and asked to stop the import of rapid test kits based on the observation by the apex health research body Indian Council of Medical Research (ICMR).
Roche said the Indian regulatory authorities had approved Biocon and Mylan's products as Trastuzumab, but it was unclear if these met the criteria for biosimilar products.
In a video, Ramdev was allegedly heard saying, "Allopathy is a stupid science and medicines such as Remdesivir, Fabiflu, and other drugs approved by the Drugs Controller General of India have failed to treat COVID-19 patients." His remarks caused massive outrage and the IMA sent over a legal notice to him.
Dr Reddy's Laboratories on Friday soft-launched imported COVID-19 vaccine Sputnik V, with Deepak Sapra, a senior executive of the drug-maker, taking the first shot in Hyderabad.
Sale of antibiotics is under the scanner. Government to go tough on misuse of these drugs.
Dabur Pharma launched its new nano technology-based chemotherapy agent Nanoxel in the country on Thursday.
Paul noted that "three to four months from now, there will be other vaccines and the stockpile will be even bigger. "And more acceleration can be brought about in the vaccination programme," Paul added.
According to sources, around 10 crore doses of the Sputnik V vaccine is likely to be imported for emergency use in the country in the next six to seven months.
The approval by the Drugs Controller General of India comes following recommendations by the Subject Expert Committee on COVID-19 of the Central Drugs Standard Control Organisation.
Earlier this week, AstraZeneca said it had paused the trials because of 'an unexplained illness' in a participant in the study.
"The phase-III trial of 'Covishield' vaccine will begin at Sassoon hospital from next week. It is likely to start on Monday. Some volunteers have already come forward for the trial. "Around 150 to 200 volunteers will be administered the vaccine candidate dose," Dean of the state-run Sassoon General Hospital Dr Muralidhar Tambe said.
Traction for its specialty portfolio, a strong showing in the domestic market, and better regulatory compliance are positives for the country's largest pharmaceutical (pharma) company, Sun Pharmaceutical Industries. Given the triggers, some brokerages have increased their earnings per share estimates and target price for 2024-25 (FY25). This should sustain the momentum for the stock, which has been one of the major pharma gainers in 2023-24 (FY24), rising 57 per cent. It is currently trading at Rs 1,547 per share.
The DCGI's nod came after the subject expert committee on COVID-19 of the CSDCO last week recommended granting emergency use authorisation to Covovax for the age group of 7 to 11 years.
FDA had also issued warning letters to Ranbaxy's Paonta Sahib and Dewas facilities as it found extensive problems and deviations from manufacturing norms.
Raising hopes for multinational pharmaceutical research companies, India has begun a consultation on steps to ease the existing clinical trial norms to allow Indian volunteers to be subjected to first-in-human phase I studies of potential medicines developed abroad.
Move follows a spate of international regulatory enforcements on Indian drug firms.
The vaccine option for this age group would only be Covaxin, according to guidelines issued by the Union Health Ministry on December 27.
The company has developed detailed logistical plans and tools to support effective vaccine transport, storage, and temperature monitoring. Sohini Das and Ruchika Chitravanshi report.
"The guidelines would cover all ethical issues."
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