Ranbaxy Laboratories, set to be merged with Sun Pharmaceutical Industries, might again have to pay a hefty penalty to the US authorities for alleged violations at its Toansa factory in Punjab.

The govt as well as the central drug regulatory agency have been cautious on approving any clinical trial after SC instructions

Proposals from leading pharmaceutical companies such as Novo Nordisk, Cadila Pharmaceuticals, Wockhardt, Novartis, Roche and Reliance Life Sciences for conducting clinical trials were recently rejected by a regulatory committee, formed following the Supreme Court’s directions to supervise tests of new medicines on human beings.

After the government failed to include the traditional stream of medicines in the Drugs and Cosmetics (amendment) Bill, 2013, it is now mulling a separate legislation to regulate systems such as ay

Only President's nod needed for it to become law

Fifty-seven years after the first Companies Act was enacted and over 20 years after liberalisation, India on Thursday inched closer to bringing more contemporary issues, such as corporate governance, investor protection, corporate social responsibility and measures to check frauds, under the legislation.

Pharma companies oppose vociferously 45 days' time period given to them for replacing existing stocks

Taking their cue from Cipla and Alembic, many in the pharmaceutical industry have challenged the new drug price fixation orders that were to be implemented from July 29. The move is expected to delay the introduction of low-priced medicines in the market.

Move to ensure compliance with recent guidelines; discrepancies to attract severe action

The country's apex drug regulator plans periodic inspection of clinical trial sites to ensure these comply with the recently issued guidelines. If discrepancies are found, strict action is to be taken against the company and the trials might also be suspended, said a senior official in the the Drug Controller General of India (DCGI) office.

Move comes in the wake of repeated slamming by the SC and the Parliamentary committee on health and family welfare

The government is considering framing a separate policy for the approval of medicines, as well as clinical trials conducted in India - in a move that is expected to strengthen regulation on the pharmaceutical industry and ensure patient safety in the country. The Union Ministry of Health and Family Welfare has constituted a committee, headed by Ranjit Roy Chaudhury, advisor in the health ministry, to formulate a policy "for approval of new drugs, clinical trials and banning of drugs".

Despite clinical trials coming under scrutiny, nothing much has changed on ground as many irregularities continue to exist. While the office of the Drugs Controller General of India (DCGI) is still struggling to accumulate data, compensation had been paid only in 50 per cent of the clinical trial death cases so far, sources said.

According to data from the drug controller's office, between January 2005 and June 2012, there were 80 deaths due to clinical trials. However, compensation has been paid in only 40 cases pertaining to 2008-2011. Pharmaceutical companies are yet to pay compensation to victims of trials during 2005-08, and for those who died in 2012.

Delhi-based biotechnology company Panacea Biotec is awaiting a nod from the World Health Organization (WHO) to resume supplying vaccines for the world immunisation programme from its units at Lalru (Haryana) and Baddi (Himachal Pradesh).

Speaking to Business Standard, a senior company official said, “We expect WHO officials to visit our units in Lalru and Baddi for prequalification next month. Recently, we had shifted the Easyfive pentavalent vaccine to our new unit in Baddi and once the plant is approved by WHO, we will be able to resume supplies for its immunisation programme.”

Firms, foreign and Indian, reiterate they follow the rules fully earlier, SC had rapped govt for gaps in law and enforcement, including on compensation

Despite courts slamming the authorities over the monitoring of clinical trials in the country, the number of deaths caused by the adverse impact of drugs in these processes has risen. Data from the drug controller’s office, reviewed by Business Standard, show 12 drug-related deaths during clinical trials in the first eight months (till August) of 2012, as against 16 in all of 2011.