Companies, reporting a standalone net profit during a year, will now have to spend mandatorily on corporate social responsibility (CSR), even if the parent group is registering a loss.

Analysts say the new mechanism would impact revenues in the short term only

The Indian pharmaceutical industry is likely to see a dip in valuations in the near term as a result of the recent pricing policy that aims to intensify the regulatory hold over essential drugs. Profit of major drug makers, including that of GlaxoSmithKline (GSK) Pharma, Abbott, Cipla, Ranbaxy and Cadila could be hit the most. But, analysts are optimistic that the revenue impact might not last for more than 18 months to two years.

Chidambaram to be special invitee at Friday?s review meeting SC wants clear policy by November 27 hearing

The long-pending pharmaceutical pricing policy revamp, awaiting Cabinet approval, has been sent back to the group of ministers (GoM) which finalised it. The prime minister’s office (PMO) wants the GoM to address concerns raised by the finance ministry. Finance Minister P Chidambaram, not part of this GoM, would be a “special invitee” to the panel’s meeting scheduled for Friday. The GoM is headed by Agriculture Minister Sharad Pawar.

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.

Mandatory ethics panel oversight, explanation within 30 days of a death & compensation rules coming

The Union health ministry and the drug regulator’s office are preparing to introduce norms and notifications to monitor clinical trials in a better way. In the wake of criticism of the existing guidelines, the ministry has planned to make it mandatory for every clinical trial site to have an internal ethics committee. It wants these committees to be registered with the drug regulator. The ministry is also working on norms for payment of timely compensation to victims in such trials.

Companies say they follow global standards in India as well

Drug majors such as Novartis, Pfizer, Bayer Healthcare, Bristol Mayer Squibb, Sun Pharmaceutical and Dr Reddy’s Laboratories were allegedly involved in clinical trials in which 438 persons died in 2011, according to confidential government data reviewed by Business Standard. While the companies argue they follow the global standards, experts point at the absence of sound regulations as the main culprit. Although the number of deaths in clinical trials has been growing through the years, it fell in 2011 from the previous year mainly because of flat growth in the clinical research market in India.

Can develop generics only by referring to an India-approved innovator biologic drug

Companies such as Biocon, Panacea Biotec and Avesthagen will now have to follow a fresh set of norms while seeking marketing approval for their biotech products in India. The new norms mandate that companies can develop a biosimilar or a biotechnology generic drugs only by referring to an innovator biologic drug approved in India. The guidelines, though, fail to address the issue of testing of such drugs with no details on patient size for clinical trials.

All generic pharmaceutical companies, including Ranbaxy Laboratories, Cipla, Dr Reddy’s Laboratories, Lupin, Glenmark and Torrent Pharma, might soon have to pay a fee to the US drug regulator when they seek its permission to sell their products there.

America is the world’s largest drug market. A Generic Drug User Fee Act is on the way, to enable the US Food and Drugs Administration (FDA) to levy a user fee of around $100,000 on each generic drug application filed for approval, it is learnt. The new norms are likely to be introduced from October.

The Competition Commission of India (CCI) has questioned the coordinated pricing strategy of state-owned oil marketing companies (OMCs). It plans to write to these companies over the matter soon.

“The coordinated approach of OMCs is not only impacting consumer interest, it is also likely to create entry barriers for private players in the sector. We will write to them about it soon,” a senior CCI official told Business Standard.

Glenmark Pharmaceuticals is set to enter the final stage of clinical trials for its new drug, Revamilast, across several countries this year. It is meant for treatment of inflammatory disorders like asthma and rheumatoid arthritis. Glenmark may soon seek approval for Phase-III trials in the US, UK and India.

“Glenmark plans to file an IND (Investigational New Drug application) for Revamilast in the US in the third quarter of the current financial year. The company intends to initiate Phase-III trials for at least one indication by the end of FY13,” chairman and managing director Glenn Saldanha told Business Standard.