The long drawn fight of the National Pharmaceutical Pricing Authority to recover more than Rs 300 crore as overcharged amounts from 50-odd pharma companies during the seven year period appears to have come to an end early this month with the Supreme Court's verdict finding the companies are at fault. The apex court set aside an earlier judgement of the Mumbai High Court which had freed seven essential bulk drugs and their formulations from the DPCO, 1995. The Supreme Court, in its order, has also asked the High Court to consider afresh the relevant provisions laid down in the Drug Policy 1994 which formed the basis for the DPCO, 1995. The NPPA has now started issuing notices to companies asking them to pay back 50 percent of the overcharged amounts by violating notified prices of seven drugs namely ciprofloxacin, norfloxacin, doxycycline, salbutamol, theophylline, cloxacillin and glipizide. The companies which are required to pay up huge amounts to the NPPA include top and respected pharma companies of the country like Cipla, Ranbaxy, USV, Unichem, Torrent, etc. As per the NPPA figures, the largest amount of Rs 200 crore to be recovered is from Cipla and it has already received a notice to deposit Rs 100 crore as 50 percent of the total amount. Ranbaxy, the number one pharma company of the country has to pay the second largest amount, estimated at Rs 50 crore to NPPA. Suprisingly, there are no serious protests or objections to the recovery move of the NPPA this time. Just one of these companies filed a review petition against the verdict in SC so far. It gives an impression that the companies are falling in line at last. In fact, the Cipla chairman at the company's annual general meeting recently even told the shareholders that it has enough funds to pay to NPPA while answering a question in this regard.

NPPA and other government bodies regulating the pharmaceutical industry are finding it increasingly difficult to enforce various statutes as pharma companies often challenge these rules and move court. With the country's judicial system is what it is and the government defence in most litigations being usually weak, implementation of rules and regulations get hijacked or unduly delayed to the detriment of the public at large. The blatant violation of the DPCO, 1995 by these highly profit making and cash rich companies and the inability of NPPA in enforcing its orders all these years is only one such many offences the drug companies indulge in. Lack of public understanding of the complexities of drug pricing and other regulatory and safety issues enable pharma companies to flout the rules rather easily. They also know the inability of drug control authorities to track all the offences in time. To bring some degree of regulatory discipline in Indian pharma industry is going to be quite tough under the current administrative system. Granting judicial or semi judicial powers to key government departments or bodies regulating pharmaceutical industry should enable implementation of rules and regulations more efficiently.