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India

Latest Headlines

Latest Headlines

Trans-Pacific Partnership push waits on cue from Obama's India visit

SINGAPORE-- India is not a member of the 12-nation Trans-Pacific Partnership, but its intellectual property rules governing pharmaceutical patents lie at the core of a dispute ginning up this year to reach a final agreement. India's resistance to relaxing its rules has been a model for the emerging-market members of the TPP to seek similar compulsory licensing arrangements for generic drugs.

Belgian company investing in Indian API plant

Indian drugmaker Dr. Datsons Labs has told the Bombay Stock Exchange it expects a $17 million investment from a Belgium-based nutraceutical maker which wants access to one of its API facilities. According to  VCCircle, the structure of the deal was not disclosed in the filing but Dr. Datsons said Eubage Laboratory intends to invest in its manufacturing operations and also outlicense 20 of its products to the Indian drugmaker.

Takeda eyeing vaccinemakers as entry point to India

SINGAPORE-- Takeda Pharmaceutical has identified a handful of Indian vaccinemakers as targets for M&A or other deal structures as it gets ready to take a plunge into a market that saw rival Daiichi Sankyo find nothing but trouble, according to sources that have spoken to executives at the Japanese company.

India issues draft bioequivalence request format for drugs aimed for export

SINGAPORE--A uniform format by India's Central Drugs Standard Control Organization (CDSCO) to file requests for bioequivalence studies in India on drugs manufactured for export put into a draft for comment.

U.S. Supreme Court ruling on Copaxone triggers questions in generics-minded India

The U.S. Supreme Court may have handed the Delhi High Court in India something else to ponder in mulling the use of compulsory licensing ahead of a possible hearing next month.

U.K. expands Wockhardt ban

In 2013, U.K. and European regulators banned most products from a Wockhardt plant in India that was found faking data, but the U.K. allowed it to continue shipping a few that were required for essential medicines. This week, the U.K. stiffened the action to include all active ingredients from Wockhardt's plant in Chikalthana, a facility the FDA has also banned from shipping to the U.S.

India makes move to reduce reliance on Chinese APIs

Authorities in Himachal Pradesh have responded to calls to reduce restrictions on bulk drug manufacturers to help relieve India's reliance on Chinese APIs.

India opens medical device industry to foreign direct investment

India's medical device industry will officially open Jan. 21 to unlimited foreign direct investment as the government kicks off what is expected to be a year of vast changes in the way it regulates the products.

India's Himachal Pradesh state eyes foreign investment in bulk drugs

India's state of Himachal Pradesh, known as Asia's pharmaceutical hub, is taking steps to make its bulk-drug industry more attractive to foreign and other investors, but finds attempting to do so a hard slog. The action, and that of other states, is considered key to reducing India's reliance on imports of active pharmaceutical ingredients, mainly from China.

Gilead to appeal India patent ruling on niche Sovaldi claim

Gilead Sciences said that an India patent office ruling on hepatitis C drug Sovaldi (sofosbuvir) only affects an application covering part of the active ingredient and that the larger validity of the uniqueness of the product remains intact as does a path-breaking patient access for the drug.