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Drug launch within six months of controller general approval now required in India

  • Shook Hardy & Bacon LLP
  • -
  • India
  • -
  • January 24 2013

According to a news source, the Drugs Controller General of India (CG) has announced that pharmaceutical companies failing to launch their drugs

Large pharmaceutical companies look to buy niche Indian biotech firms

  • Shook Hardy & Bacon LLP
  • -
  • India, USA
  • -
  • January 13 2011

Major pharmaceutical companies are reportedly buying niche biotech firms in India to take advantage of emerging opportunities involving biosimilar drugs, which are expected to have a market share of approximately $78 billion by 2013

India Supreme Court requests removal of industry reps from safety enforcement panels

  • Shook Hardy & Bacon LLP
  • -
  • India
  • -
  • February 11 2011

Ruling on a request by a non-governmental organization (NGO), two supreme court justices in India have reportedly asked the government to remove food and soft drink company representatives from food-safety standards and enforcement panels

India ponders domestic impact of biopharma takeovers

  • Shook Hardy & Bacon LLP
  • -
  • India
  • -
  • March 10 2011

According to a news source, recent takeovers of India's key drug companies by foreign pharmaceutical interests have policymakers worried about the potential impact on domestic drug markets and prices

India biotech sector set to reach $10 billion by 2015

  • Shook Hardy & Bacon LLP
  • -
  • India
  • -
  • May 19 2011

According to a news source, India's biotechnology sector is expected to reach $10 billion in revenue by 2015

India issues draft guidelines on clinical trial and data submission requirements for new drug approval

  • Shook Hardy & Bacon LLP
  • -
  • India
  • -
  • August 18 2011

The Central Drugs Standard Control Organization (CDSCO) of India’s Ministry of Health and Family Welfare has issued draft guidelines on the clinical trial and data submission requirements that drug makers must meet before new drugs can be manufactured, marketed or imported into India

Indian officials to scrutinize pharmaceutical M&As

  • Shook Hardy & Bacon LLP
  • -
  • India
  • -
  • October 20 2011

Indian ministry officials have apparently decided that foreign companies may continue to invest in new pharmaceutical industry projects but that foreign proposals for mergers and acquisitions in this sector will have to undergo enhanced scrutiny

India’s biotechnology regulatory bill faces opposition

  • Shook Hardy & Bacon LLP
  • -
  • India
  • -
  • November 17 2011

According to a news source, the proposed Biotechnology Regulatory Authority of India Bill, 2011, was withdrawn from the Monsoon Session of Parliament after congressional members and others objected to placing the new regulatory agency under the authority of the Ministry of Science & Technology

Indian state seizes Red Bull, caffeine content above legal limits

  • Shook Hardy & Bacon LLP
  • -
  • India
  • -
  • April 6 2012

The Maharashtra Food and Drug Administration (MFDA) has reportedly seized more than 1 million cans of Red Bull, an energy drink containing 250-300 parts per million (ppm) of caffeine, on the ground that the product exceeds the 145 ppm limit for carbonated beverages

Indian official calls for passage of biotech regulatory legislation and increased VC funding

  • Shook Hardy & Bacon LLP
  • -
  • India
  • -
  • February 16 2012

A biotechnology industry spokesperson has reportedly pointed to the lack of a proper regulatory framework in India as one of several hurdles the industry will have to surmount to grow