A joint team of the state and the Centre inspected the unit and found 12 violations or deficiencies.
Margaret A Hamburg, the first commissioner of the US Food and Drug Administration (US FDA) to visit India officially, will meet heads of major domestic pharma companies such as Ranbaxy, Wockhardt, Cadila Healthcare and Lupin in New Delhi.
Donald Trump's Presidency of the United States will open new opportunities for India though certain sectors, especially pharma and IT, may face the heat if the incoming president decides to impose restrictions on imports and H1B visa regulations, experts said on Wednesday. Prime Minister Narendra Modi's friendly relationship with Trump will have a positive bearing on Indo-US relations but India may have to adapt its strategies to maintain cooperation in areas of mutual interest.
Proposes to increase Exemption Limit for Small Service Providers from Rs 10 lakh to Rs 25 lakh.
US-based Merck is confident that its cervical cancer vaccine Gardasil will help it to secure a position among the country's top five drug companies in the next five years.
Various industry bodies have sought immediate government intervention through the imposition of anti-dumping duties, claiming India has seen a surge in imports of Chinese goods over the past two weeks.
Indian government has set up a panel to fix prices of patented drugs in the country.
The Bombay high court on Wednesday ordered for fresh testing of Johnson & Johnson baby powder samples and permitted the company to manufacture the product but to not sell it, as per the Maharashtra government order. The company had filed a petition challenging two orders of the state government- one dated September 15 cancelling the license and the second dated September 20 ordering to immediately stop manufacturing and sale of the company's baby powder product. The orders were passed by the joint commissioner and licensing authority of the state Food and Drug Administration (FDA).
US firm Mylan NV received a stern warning from the FDA in August for faulty manufacturing practices at three of its India drugmaking plants.
Various domestic companies such as Ranbaxy, Wockhardt and Agila Specialities recently came under the US FDA scanner for lapse in 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.
Pharma firms will have to affix barcodes on consignments of all tertiary level packaging, such as cartons, following a government order.
Samples of the powder for babies did not conform to standard pH value during a laboratory test, the regulator said.
WakeupWalmart.com, an anti-Wal-Mart website which belongs to the United Food and Commercial Workers Union, came out with a report two days ago titled, 'Wal-Mart's vaunted $4 prescriptions supplied by disgraced Indian manufacturer.' UFCW claims to have a membership of over 1.3 million workers in the US and Canada. WakeupWalmart.com mainly campaigns for the rights of Wal-Mart employees and consumer interests.
Generic drug sales in the US, that power the business of such leading Indian drug manufacturers as Ranbaxy, Dr Reddy's, Sun Pharma, Lupin and Zydus Cadila, will face competition soon, as big US wholesalers decide to outsource their requirements from upcoming Indian manufacturers.
AstraZeneca on Wednesday announced that it had filed separate patent infringement actions in the United States District Court, Delaware, against seven generic drug manufacturers, which have submitted abbreviated new drug applications (ANDAs) with the US Food and Drug Administration (FDA) seeking marketing authorisation for Crestor.
The top 300 pharmaceutical brands in the country will now bear a quick response (QR) code on their packaging to rein in spurious drugs and ensure better traceability.
The United States Food and Drug Administration on Tuesday banned the import of more than 30 generic drugs manufactured by Ranbaxy Laboratories Limited alleging that poor quality control at the firm's factories could be harmful to users of these medications used to treat everything from high cholesterol to Type 2 diabetes to everyday allergies.
Last year, India's agricultural exports to the United States topped $5 billion.
A critical drug developed on a DRDO technology for radiological and nuclear emergencies has received approval from the Drugs Controller General of India (DCGI), the defence ministry said on Tuesday.
Oral paracetamol and another cough medicine manufactured by companies based in Mumbai and Punjab were found to be "sub-standard or found to be containing toxins", reports Sohini Das.
Dabur has moved quickly to take advantage of the ban.
Small scale drug makers fear that they may have to shell out anything between Rs 20 lakh (Rs 2 million) to Rs 1 crore (Rs 10 million) for acquiring land and equipment as mandated by the new GLP.
India's pharmaceutical industry is losing around Rs 500 crore (Rs 5 billion) annually on account of destruction of expired drugs, hitting the bottom line of drug manufacturers, especially the small and medium ones.
After registering a net profit of Rs 25.1 crore in Q3FY25 and consolidated revenues growing by 7 per cent on a like-for-like basis, Siddharth Mittal, chief executive officer (CEO) and managing director, Biocon, told Sohini Das/Business Standard in a virtual interaction that local manufacturing in the US is a trade off between cost and qualifying to do business there.
The drug controlling authority in Chhattisgarh on Thursday raided and sealed a unit of an antibiotic manufacturing company, whose product was used in sterilisation camps in Bilaspur district where 13 women died and several others fell ill.
The drugs manufacturing industry is on a state of alert following two landmark developments over a cancer treatment medicine.
Indian pharmaceutical companies are stepping up their efforts to combat the problem of counterfeit drugs, employing a variety of strategies, from packaging innovations to engaging private investigation agencies. The stakes are high, as counterfeit medicines not only harm consumers but also tarnish the reputation of leading brands.
The PhRMA's observation is significant against the backdrop of Swiss pharma major Novartis AG's decision to relocate its R&D investments from India.
The industry feels that prices of active pharmaceutical ingredients (APIs) can go up in the range of 5-15 per cent.
Amid the ongoing global tariff war, Reserve Bank Governor Sanjay Malhotra on Wednesday said he is more worried about its impact on growth than inflation. Speaking to the media after presentation of the first bi-monthly monetary policy for the current financial year, Malhotra said, RBI has reduced the growth forecast for 2025-26 by 20 basis points to 6.5 per cent.
The ability of Indian pharmaceutical companies to command higher margins in international markets is helping sustain business.
Overall slowdown in the economy and growing volumes of unbranded generic medicines in the domestic market are behind poor sales.
Pharma firm Micro Labs Ltd plans to invest Rs 100 crore (Rs 1 billion) in setting up three drug manufacturing units -- two in Bangalore and one in Goa -- next year.
