Last week, the Gujarat Food & Drug Control Administration sent a note to NPPA alerting it about selling of certain cancer drugs at exorbitant prices by some of the pharmaceutical companies in the state. Not all the cancer drugs marketed in the country are brought under price control when new DPCO was notified in 2013. Gujarat FDCA requested NPPA to include these drugs under DPCO 2013 considering the fact that they are required for thousands of poor patients in the state. Nearly 20 anti cancer drugs of different molecules available in the market are found to have huge price difference between MRP and the stockiest price according to Gujarat FDCA. Big pharmaceutical companies are usually found to be indulging in this kind of excessive profiteering and unethical trade practices while marketing essential drugs. NPPA being a Central body with no effective network of inspectors in States and Union Territories to monitor price violations and profiteering, drug companies continue to flout rules until violations are detected. Take the case of GSK in May 2014. Its attempt to overcharge paracetamol preparation was detected by Maharashtra FDA. The company claimed its product Crocin Advance containing paracetamol 500 mg is a new drug and started charging double the price than what was fixed by NPPA. GSK then had to pay Rs.47.87 crore to NPPA for overcharging Crocin Advance on May 21, 2014. The drug was also ordered to be recalled because of a stop sale order issued for its violation of DPCO 2013.
Up to the year ended March 31, 2014, NPPA detected 89 cases of overcharging after the DPCO 2013 was notified and it is possible that there could be many more undetected cases of price violations during the current year. With this the total number of drug price violation cases in the country stands at 1018 for a total overcharged amount of Rs. 3381.91 crore. As these cases are fought in different courts and are in various stages of hearing, it is difficult to assume when such a huge amount will be recovered by the government. With the new DPCO announced in 2013 covering 348 drugs, NPPA has a much bigger task now in monitoring drug prices. Circumvention and violation of the DPCO provisions have to be expected on a much bigger scale considering the track record of the Indian pharmaceutical companies. The state drug regulatory authorities in many States and Union Territories are rather weak and do not have adequate number of staff to check the malpractices of pharma companies. And officials in most state drug control administrations only monitor the breach of Drugs & Cosmetics Act. Alert and proactive state drug administrations like that of Gujarat, Maharashtra and Karnataka are not many to trace and report price violations in various parts of the country to NPPA. Therefore the proposal to have monitoring cells of NPPA in every state is possibly the best option. NPPA should act on this front without any more delay and the Department of Pharmaceuticals should help it to source out the required funds for the same.