Ramdev and Balkrishna have tendered an "unconditional and unqualified apology" before the apex court over advertisements issued by the firm making tall claims about the medicinal efficacy of its products.
According to respective company sources, Biological E is holding 200 million doses of its COVID-19 vaccine Corbevax while Bharat Biotech is sitting on a stockpile of 50 million doses of Covaxin.
Hyderabad is likely to lose its status as the pharmaceutical capital of the country if the current political turmoil in Andhra Pradesh continues and the state is bifurcated, according to the head of the Bulk Drug Manufacturers Association (BDMA).
Two employees of a drug manufacturing company in Indore were killed and six others became ill after inhaling poisonous gas leaked from the production unit. The incident took place at Rinilife Science Private Ltd in the city's industrial area on Sanver Road late on Saturday night, the police said, adding that the gas leaked in the production unit of the company. The deceased were identified as Subhash Pal, 28, and Dinesh Borana, 30, the police said today.
The letter was the latest sign of US frustration about the business environment in India.
The government is likely to extend fiscal incentives for production of toys, bicycles and leather and footwear in the forthcoming budget as it looks to expand production linked incentive (PLI) scheme to cover more high-employment potential sectors, sources said. The government has already rolled out the scheme with an outlay of about Rs 2 lakh crore for as many as 14 sectors, including automobiles and auto components, white goods, pharma, textiles, food products, high efficiency solar PV modules, advance chemistry cell and speciality steel. The scheme aims to make domestic manufacturing globally competitive and create global champions in manufacturing, and it is yielding solid results, sources said.
The government on Wednesday said Indian drug makers Ranbaxy and Cipla have approached it for assistance in manufacturing Tamiflu to fight bird flu
The Union Minister for Chemicals, Fertilisers and Steel Ram Vilas Paswan on Monday said from April 1 onwards, the prices of drugs would include local taxes.
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.
Sources say FDA letter over product and not entire facility
The company has got the approval for the generic version of Roche's anti-viral 'Valcyte', which has a total annual market of around $239 million. Ranbaxy believes that it has First-to-File status on Valganciclovir tablets, thereby, providing a potential of 180-days of marketing exclusivity which offers a significant opportunity in the future, the company said.
The Central Drugs Standard Control Organisation (CDSCO) has initiated a probe in connection with the death of 18 children in Uzbekistan allegedly linked to Marion Biotech.
Amending the earlier order, the authority on Saturday issued a fresh one allowing the firm to continue the production of these medicines.
The Delhi High Court on Friday stayed the ban on some fixed dose combination (FDC) drugs of Glaxo SmithKline, Wockhardt and Laboratories Griffon but said action against their sale could be taken in the absence of valid sale and marketing licence.
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Earlier in April, Sun Pharmaceuticals Industries announced acquisition of Ranbaxy in an all-share deal.
Glenmark said it along with its US-based partner has got the US health regulator's nod to manufacture and market two oxycodone products, used for treating moderate to severe pain, in the American market. The company's US arm, Glenmark Generics Inc and Lehigh Valley Technologies (LVT) have received US Food and Drug Administration nod for Oxycodone immediate release capsules, the company said in a filing to the Bombay Stock Exchange.
In a move to focus on its core FMCG strength, the Burman family, promoters of Dabur India, last week announced their exit from the pharma business.
Former actress Mamta Kulkarni was on Saturday named as a prime accused in a multi-crore drug racket linked to drug baron Vicky Goswami, with Mumbai police claiming that she was actively involved in the illicit activities and would seek her extradition from Kenya.
A random check had found that tests failed to prove the medicines were same as the patented drugs.\n
A day after getting a show-cause notice from the Indian regulator, senior executives from Ranbaxy Laboratories approached the drug controller's office on Tuesday afternoon, it was learnt.
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FDA had also issued warning letters to Ranbaxy's Paonta Sahib and Dewas facilities as it found extensive problems and deviations from manufacturing norms.
The South African government and large pharmaceutical companies are in combat mode regarding the proposed national policy on intellectual property that hopes to improve access to medicines for the poorer sections of the population.
K Anji Reddy from a small village near Vijaywada, quit his job with the government-owned Indian Drugs and Pharmaceuticals Limited in 1974 to set up his own company. The rest is history.
It has been approved by the European Medicines Agency for conditional marketing authorisation.
The move is in line with the NPPA's recent policy of putting a cap on prices.
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.
Lupin Ltd received US Food & Drug Administration's approval for its abbreviated new drug application for Cefuroxime Axetil tablets.
Nirma's tryst with the pharmaceutical space started in 2006 when it acquired the ailing Core Healthcare in a deal reported to be worth Rs 300 crore. The Ahmedabad-based manufacturer of intravenous fluids was subsequently renamed Nirlife. Pharma industry insiders say Nirma, which broke open the detergent market in the 1990s with low prices and massive advertising, tried an encore of the low-price strategy in pharma, but with mixed results.
Ranbaxy Laboratories Ltd said on Monday it has entered into a licensing agreement with US-based Gilead Sciences Inc for manufacturing and marketing of Active Pharmaceutical Ingredient and formulations containing anti-HIV drug Tenofovir.
A notice issued by the Indian Health Ministry at the weekend said that a government-appointed committee of experts had found that the banned combinations were "likely to involve risk to human beings, whereas safer alternatives to the said drug are available."
Drug maker Cipla always fought a lone battle to make drugs affordable in India.
Ranbaxy Laboratories on Thursday said that it had received final approval from US Food and Drug Administration to manufacture and market Ciprofloxacin.
The DCGI's approval came following recommendation by the Subject Expert Committee of the Central Drugs Standard Control Organisation.
Dilip Shanghvi founded Sun Pharma in 1983.
For the poorest 20 per cent of Indians, the expenditure on medicines alone is 85 per cent of what they spend on their health, according to the National Sample Survey.
Part research being farmed out to medical colleges, universities to cut cost and time.
Over 50 pharmaceutical companies have scaled down operations in Maharashtra and Gujarat and are moving out to states like Uttaranchal and Himachal Pradesh following steep hike in excise duty in the Union Budget.
