Drug regulators to go slow on DPCO

Sun Pharma gets interim relief from Delhi HC; potential shortage of medicines in the market force drug regulators to move cautiously

At a time when the new Drug Pricing Control Order (DPCO) of 2013 is getting implemented, state level drug regulators are in a fix as to how to enforce the new pricing order, precisely for two reasons; one a sudden crackdown is likely to cause a severe shortage of essential medicines in the market, and also as several companies have moved court challenging various provisions of the DPCO.

H G Koshia, commissioner of the Food and Drug Control Administration of Gujarat said, "Sun Pharmaceuticals, which had moved Delhi High Court earlier in July, has received interim relief as the Court has asked the government not to take any coersive action against the company till the next hearing.

The order said, "ln the meanwhile, if the petitioner furnishes the price list/supplementary list in respect of the formulations covered under various price notifications issued under DPCO 2013 and the price lists are distributed to the dealers, the State Drug Controller and the Government then in that case, the respondent shall not take coersive measures against petitioner in respect of the said formulations."

Sun Pharma had challenged the DPCO provision which mandates that all the medicines covered under DPCO should sport the new price labels within 45-days from the day the order gets implemented.  When contacted, a Sun Pharma spokesperson said, "We do not wish to comment on the issue as the matter is subjudice."

For the first set of 151 formulations, which was notified by the DPCO on June 14, the 45-day period has come to an end and the DPCO has come into effect from July 29. However, state drug regulators have decided to go slow on the process as there is ambiguity on the issue.

Koshia also pointed out that a sudden crackdown on chemists and druggists could also lead to a shortage of essential medicines in the market for patients. "Around 20 per cent of companies have already replaced old stocks with the new pricing, however, there is still at least 50-60 per cent of medicines available in the market that are selling under the old MRP. We are ready to implement the DPCO as we have collected all data related drugs that have undergone price change and have informed all state drug inspectors and chemists and other stakeholders." However, keeping in mind the larger interests of patients the Gujarat FDCA has decided to take a slow and cautious approach.

The drug regulator has also asked other companies who had approached Court to furnish copies of the court order so that there is more clarity on the issue. Industry insiders feel that with the interim relief granted to Sun Pharma, more and more pharma companies are likely to approach Court with similar pleas.

Alembic Ltd, a Vadodara based pharma company, had approached the Gujarat High Court challenging the mechanism in which the minimum price has been calculated by the National Pharmaceutical Pricing Authority (NPPA). R K Baheti, director, finance of Alembic said, "We have contested the mechanism in which the NPPA has computed the price. We have meanwhile rolled out all our new batches of medicine with the new DPCO pricing." He too added that the 45-day period of implementation is very short and impractical in the context that pharma companies would have to recall medicines from almost 600,000 chemists across the country, re-label and resend the new stock with new labelling.

Alembic, however, has not been granted any interim relief by the Gujarat High Court so far. On the other hand, owing to ambiguity on the matter and potential shortage of medicines in the market, the Maharashtra drug controller too has decided to follow the lines of Gujarat FDCA. A senior official in the Maharshtra FDA said, "We are waiting for further direction from the government authorities and have decided to move cautiously in this matter."