The Supreme Court on Monday asked the Centre to provide details of clinical trials conducted throughout the country since June 2005, their side effects, and deaths, if any, as well as the quantum o

In the past two years, clinical trials in India have come increasingly under public scrutiny. As a result, clinical research organisations (CROs), companies that conduct clinical trials for drug makers, are somewhat under pressure.

However, leading CROs in the country, such as Quintiles, are riding on the hope that they will be able to redeem the opportunities in the sector once the regulatory system is set right. As that happens, the threat to this area, where India till recently had a lead over China, shall be overcome, and things will be back to normal.

Bench issues notice to all States also

The Supreme Court on Monday expressed serious concern over clinical trial of drugs on human beings and issued notice to all States through their Chief Secretaries for their response. Hearing a petition filed by the Swasthya Adhikar Manch, highlighting the menace, a Bench of Justices R.M. Lodha and Anil R. Dave also wanted the Centre to furnish details of deaths, if any, of the subjects of clinical trials.

Why don't you sell it for Rs.5?

GoM had proposed a new pricing mechanism, but judges had said at an earlier hearing the current formula should stay

The government is likely to formally tell the Supreme Court about the need to change the existing drug pricing mechanism. At the previous hearing on the issue last Wednesday, SC had said: “While adjourning the case, we make it clear that the government should not alter the price structure of the drugs as notified vide Notification dated 13.07.1999 and similar notifications which may have been issued thereafter.” The next hearing is on the coming Tuesday.

A Supreme Court order on drug price control on Wednesday has caused confusion with some interpreting it to mean the retention of cost-based pricing which will help patients.

The Supreme Court has given the government a week to frame a final pharma pricing policy, failing which the apex court may pass an interim order in public interest. A Bench, headed by Justice G S Singhvi, posted the matter for next hearing on October 9.

In an observation, the court today asked the government not to alter the existing pricing system for essential medicines, according to news agency PTI. “We make it clear that the government should not alter the price system as notified on July 13, 1999 and similar subsequent notification,” PTI quoted a Bench headed by Justice G S Singhvi as saying.

Wants government to firm up a date by which essential drugs will be notified

The Supreme Court on Wednesday told the Union government that in the name of bringing essential drugs under pricing control it should not alter the price system. A Bench of Justices G.S. Singhvi and S.J. Mukhopadhaya told senior counsel Ashok Bhan, appearing for the Centre: “The government should not alter the drug price system. You firm up a date by which essential drugs would be notified.”

The All-India Chemists and Distributors’ Federation has expressed displeasure at the method proposed by the Group of Ministers to fix the cost of 348 drugs that have recently been brought under the National List of Essential Medicines.

AICDF president Kailash Gupta said: “The method recommended by the GOM in fixing the cost of these medicines is based on the average of market price of best selling brands which we feel is totally wrong.’’