Low growth visibility and trouble with regulators have resulted in lack of interest from investors
An end to Sun Pharma founder Dilip Shanghvi's woes are not in sight.
India is engaged with American entities for procurement of COVID-19 vaccines from the United States and their possible manufacturing in the country subsequently, the Ministry of External Affairs said on Thursday.
If the DCGI grants regular marketing authorisation, Covishied will be the second vaccine in the world to receive such approval.
There are also lingering concerns over the culture of misuse of pharmaceutical products in India, which has, in the past, led to other drugs becoming increasingly ineffective.
India consistently ranked among the top three countries whose products were rejected for import by the regulator.
Suit alleges fraud by hiding significant deficiencies in CGMP regulations enforced by US health regulator.
The move comes in the wake of many facilities of Ranbaxy in India being barred by the US Food and Drugs Administration for supplying medicines to the US.
Rosier year-end seen for Indian pharma thanks to faster US approvals.
Ranbaxy Laboratories and the US health regulator are reportedly negotiating a settlement.
Some Indian generic drugmakers are, however, uncertain about the pace of approvals in the near future.
Food and Drug Authority Ghana said in a statement that officials of Bliss GVS Pharma of India and Ghanaian drug maker Tobinco Pharmaceuticals have apologised to it for importing 'fake malaria medicine' to Ghana to treat malaria in children.
The country's drug companies have attracted the highest number of enforcements from the American drug regulator in 2013, a year that has seen the US Food and Drug Administration turning stricter to ensure compliance levels and quality of medicines.
The FDA had imposed a ban on the company's Waluj plant in May.
The US president said the drug has gotten a bad reputation only because 'he was promoting it'.
Ranbaxy's US factory, Ohm Laboratories, is learnt to have got a clean chit from the American regulator. This US facility was under surveillance of the Food and Drug Administration (FDA) since the end of 2012.
'WHO issued an emergency use listing for Covovax, expanding the basket of WHO-validated vaccines against COVID-19. The vaccine is produced by the Serum Institute of India under licence from Novavax,' the world health body said in a tweet on Friday.
Ranbaxy, which is 63.5 per cent-owned by Japan's Daiichi Sankyo Co and gets more than 40 per cent of its sales from the United States, did not immediately respond to a request on Wednesday for comment on the FDA observations.
The US Congressional committee, which is inquiring into the country's Food and Drug Administration's handling of drug-marketing approvals of India's leading drug-maker Ranbaxy, has extended its probe into similar permissions given to Iceland's Actavis.
Fast Moving Consumer Goods major Nestle may face more action by the Uttar Pradesh Food Safety and Drug Administration, which is testing more batches of Maggi after ordering recall of a batch of about 2 lakh packs of the instant noodles due to higher than permitted levels of lead and a food additive.
The recall is the latest in a series of problems to hit Ranbaxy, which has had all its India factories stopped from sending drugs and ingredients to the United States.
The Indian Council of Medical Research will start national-level sero surveys to assess the spread of Covid-19 and all states/Union territories should also be encouraged to conduct them so that information from all geographies can be collected, the Union health ministry said on Friday.
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.
Travel companies are expecting a heavy rush to the US following the withdrawal of curbs on fully vaccinated travellers from select countries, including India, on November 8. The move will benefit those holding long-term tourist, business, and work visas. Also, new and extra flights by Air India and American Airlines are expected to provide better travel options.
'Supplies should start moving to the Serum Institute without any impediments.'
Of the 23 Indian billionaires mentioned in the Bloomberg Billionaires Index, only one saw a reduction in net worth, with the companies owned by most of them outperforming the Nifty 50 index by a big margin.
With the US education system operating independently from the government, universities are adopting varying strategies when it comes to Covid vaccination.
Nestl India is preparing a blueprint for a possible relaunch.
Global generic drugs producer Sandoz has opened its third plant in India at Navi Mumbai with annual production capacity of one billion tablets and capsules.
The recent recalls come amid increased FDA scrutiny of medicines produced in India.
Unhappy with Chinese machinery and raw materials they have been importing so far, Pakistani pharmaceutical companies are now longing to increase their business ties with India, and asked New Delhi to relax the "stringent visa norms".
Dinesh Thakur is famous for exposing Ranbaxy safety problems
The company has been held responsible for the violation of the Drugs and Cosmetic Act, 1940 and the rules framed in 1945.
Various domestic companies such as Ranbaxy, Wockhardt and Agila Specialities recently came under the US FDA scanner for lapse in manufacturing practices.
Nestle refused to regret the mistake in a public statement.
As the pandemic spreads and the urgency for effective treatment of COVID-19 mounts, several countries, including the US, have started relying heavily on HCQ, majorly used in the treatment of malaria and rheumatoid-arthritis.
Trump has been aggressively promoting the use of hydroxychloroquine in the treatment of COVID-19 patients.
The weakness in the stock was because of inspections by the American drug regulator at its Halol plant in Gujarat which resulted in eight observations, as well as a downward revision of speciality drug payoffs.
Indian drug companies have cornered an overwhelming majority of drug approvals under the US President's Emergency Plan for AIDS Relief.
Company is among the few companies in the sector getting pulled up by FDA for violations at its factories in India.
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