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.

In yet another twist to the Ranbaxy scandal, the drug regulatory authority of the UK government has issued a statement clarifying that they have found no evidence that any of Ranbaxy’s products in

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.

Accepts GoM's final recommendations without changes, say sources

The Cabinet today endorsed the recommendations of a Group of Ministers’ (GoM) on a revised National Pharmaceutical Pricing Policy, giving shape to a long-pending issue. The government did not give out details of the decision. According to sources, the Cabinet has imposed a cap on prices of 348 essential medicines at the arithmetic average of prices of all drugs in a particular segment with more than one per cent market share, in line with the GoM’s new recommendations.

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.

New Delhi The government is planning to tighten the regulatory landscape of the R4,500-crore vitamins and neutraceuticals market in the country. Different arms of government — the drug regulator, Drug Controller General of India (DCGI), and the food regulator, Food Safety and Standards Authority of India (FSSAI) — are taking a series of steps to correct the anomaly of multivitamins getting marketed as dietary supplements.

First, DCGI may make it mandatory for all such vitamin manufacturers who use any drug as ingredients in their products to take a no-objection certificate from the government. This is likely to become compulsory for manufacturers who use medicinal ingredients for 'non medicinal use', which would include food supplements.

A suo motu study on drug pricing by the Ministry of Corporate Affairs has revealed exorbitant profit margins on 21 common drugs manufactured by Indian companies.

New Delhi A suo motu study on drug pricing by the Ministry of Corporate Affairs has revealed exorbitant profit margins on 21 common drugs manufactured by Indian companies.

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.

Leading pharma companies including GlaxoSmithkline, Pfizer and Ranbaxy sell commonly used drugs at a rate 10 times the cost of production, a study by the Corporate Affairs Ministry has found.

A study by the Cost Audit branch of the MCA found drugs like Calpol manufactured by Glaxosmithkline, Corex Cough Syrup by Pfizer, Revital by Ranbaxy Global, Omez by Dr Reddy's Labs, Azithral by Alembic and several others were being sold at a mark up of up to 1,123 per cent over the cost of production.