In a move, which will affect most multinational pharma majors, the National Pharmaceutical Pricing Authority is planning to conduct an annual review to see which bulk drugs satisfy the criteria to come under price control.
Death penalty for fake drug makers
Pending clearance of the revised drug pricing policy, the authority has decided to review the production data of all bulk drugs to see which ones satisfy the price control criteria.
| The plan |
| Authority to review the production data of all bulk drugs
Move likely to affect a number of companies with new molecules This is the first time that the NPPA is attempting an annual review The Supreme Court has laid down parameters for inclusion and exclusion of drugs |
This may affect a number of companies whose new molecules are expected to come under control.
The exercise follows Ranbaxy's contention that some of its drugs would have come out of price control if the NPPA conducted annual reviews.
The authority will contact all manufacturers of bulk drugs to collect production figures.
"We will write to all pharmaceutical associations asking their members to cooperate and provide data," said Arun Kshetrapal, NPPA chairman.
This is the first time that the NPPA is attempting an annual review.
Even though the Drug Price Control Order, 1994 states that the list of drugs under the price control criteria should be updated every year, it has not been done so far.
"The Supreme Court in August laid down parameters to be followed for inclusion and exclusion of drugs. We will look afresh at all bulk drugs being manufactured in India and rework Schedule 1," Kshetrapal said.
The apex court had said export sales should not be taken into account in computing turnover of a drug and ORG data do not give an exhaustive account of the turnover of bulk drugs and should not be the sole guide in estimating turnover. Also single ingredient formulators alone should be taken into account, when determining criteria, it added.
For the annual review, data on over 600 bulk drugs being made in India will be studied.
If the Drug Price Control Order, 2001 is cleared or if a new court judgment comes, the situation will change; but as of now, the pricing authority plans to rework the list of price controlled drugs each year.
Once the format for data required is finalised, companies will be given 30 days to provide the data.
Non-compliance, with companies refusing to provide data, could be a problem, but in that case the NPPA would collect data from "alternative sources," he added.