(Reuters)—The U.S. Food and Drug Administration (FDA) has raised concerns over quality controls at a Mylan NV manufacturing plant in India, according to a warning letter from the agency dated April 3. India-based drug manufacturing facilities have been criticized by the FDA in recent years for violating quality standards, as the agency increases oversight of…
On the Road in Rajasthan: Vehicular-Caused Bone, Joint Damage in India
In the good old days, physicians routinely made house calls. The decision to visit the literal bedside of a patient was practical: hospital services were primitive and often offered too little benefit to justify an emergency journey by the patient. These physicians carried leather bags, sometimes called Gladstones, that were filled with instruments for eventualities…
Sun Pharma Gets U.S. Subpoena over Generic Drugs Pricing
MUMBAI (Reuters)—The U.S. Department of Justice (DOJ) has subpoenaed India’s largest drugmaker Sun Pharmaceutical Industries Ltd. seeking information about the pricing and marketing of the generic drugs it sells in the U.S., the company said on Saturday. The DOJ’s antitrust division has also asked Sun Pharma’s U.S. unit for documents related to employee and corporate records…
U.S. & EU Regulators Urge Indian Drug Companies to Step Up Standards
MUMBAI (Reuters)—U.S. and EU drug regulators called upon India’s pharmaceutical sector on Tuesday to step up efforts to improve manufacturing standards and ensure the reliability of data if it is to maintain its dominance in the generic drugs industry. India’s $15 billion pharmaceutical industry, an increasingly important global supplier of cheaper generic medicines, has been…
U.S. Bans Another Indian Drug Plant over Production Quality
MUMBAI (Reuters)—The U.S. Food and Drug Administration (FDA) has banned imports from another India-based drug manufacturing plant over quality control concerns, making it the 10th site in the country this year to face such action. The FDA’s import alert on Mumbai-based Polydrug Laboratories Pvt Ltd’s Ambernath manufacturing plant comes two months after Canada banned the…
Hamstrung by Red Tape, Hospital Operators Buy Their Way into India
NEW DELHI (Reuters)—For nearly two years, Parkway Pantai has delayed the opening of its 450-bed India hospital, the Singapore-based medical firm’s bid to cash in on one of Asia’s fastest growing private healthcare markets, as it waited for the necessary permits. Parkway, a unit of the world’s second largest healthcare group by market value IHH…