Pharma frauds – dealing with them

The pharmaceutical giant, Ranbaxy, is fined with 500 million US dollar (approximately Rs. 2750 crore) by the US Justice Department for selling adulterated drugs in US market. The company is charged with making false, fictitious and fraudulent claims for winning US FDA approval. This has raised serious concern among the health professionals and in the minds of consumers. The case is related to manufacture and distribution of adulterated drugs made at two of its units located in Himachal Pradesh and Madhya Pradesh. Can the pharmaceutical companies be trusted? Once, the Ranbaxy was the India’s pride!.

Now the Swiss pharma major Novartis is too charged with healthcare fraud. US Government has sued Novartis claiming that it paid kickbacks to pharmacies to switch kidney transplant patients from competitor’s drug to its own. The Merck and Co paid US dollar 950 million to settle the case related to off label promotion of Vioxx for rheumatoid arthritis (Vioxx is recalled from market in 2004). Now let’s see few such instances in our own country. A pharma major Panacea Biotec has reported to have recalled a batch of easy five TT vaccine from the market following a controversy. This is a pentavalent vaccine meant for prevention of diphtheria, pertussis, tetanus, hepatitis and haemophilus influenza type B in children. The vaccine is recently introduced into the immunization programme in selective states. The controversy arose when the Tamil Nadu Drugs Control Department seized a batch of this vaccine for alleged re-labelling of the products. The vials of this batch of vaccine are re-labelled by pasting a new label over the old one extending the expiry date. What a dare devil task of fooling the people of the country and risking the life of children with the use of an expired vaccine! The company initially claimed that it has received permission from national drug regulatory authority (CDSCO) to re-label the products with extended shelf life. This has been denied by the office of DCGI. There has been reported death of a child after administration of the pentavalent vaccine. Kudos to Tamil Nadu Drugs Control Department for taking this action!  But is it enough?

The Parliamentary panel attached to the Ministry of Health and Family Welfare raised serious allegation of approving drugs without clinical trials just based on recommendation of few physicians. The Indian law requires that the drug needs to be tested for safety and efficacy before being approved for marketing. Though in last May (2012), it has been pointed out by the Parliamentary Committee, no appreciable action has been initiated except constituting few committees to examine the issue. There are reports of 33 untested drugs in Indian market affecting the safety of lakhs of people who are using these medicines. The pharma companies managed to send the recommendation of few physicians. Surprisingly the recommendations are in same   wordings!

It is believed that all drugs available in the market are of good quality as they (the batch) have been tested for quality compliance before released for marketing. But, we see frequent detection and seizure of not of standard quality medicines. With the implementation of quality assurance programme, it is expected that there would be no defective or not of standard quality medicines. The Good Manufacturing Practices (GMP) are mandatory. Almost all pharmaceutical companies have adopted the quality assurance programme. But, despite of these zero defect strategies, we find the medicines of even the reputed and bigger pharmas failing quality tests. Adding some transparency to the quality issue, the CDSCO has started publishing the list of medicines which failed the quality tests by Central Authority. Does the Central Authority or the State Authority question and punish the pharma companies for marketing such not of standard quality medicines? We rarely see any voluntary withdrawal or recalling of medicines.

In addition to quality issues, there are reports of overcharging by the pharmaceutical companies. The economic consideration has been proved as one of the major reasons of poor access to medicines in India. People pay seventy five percent of their health expenditure on medicine. This is an out of packet expenditure. The Drugs Price Control Order (DPCO) (1995) was expected to control the price of scheduled drugs. But the companies continue to violate the norms of DPCO. The National Pharmaceutical Pricing Authority failed to even completely recovering the over charged amounts. During 2011-12 alone 26 fresh cases were raised for overcharging. Will our pharmas look the business from societal need too? Now the New DPCO 2013 is announced by Department of Pharmaceuticals.

The spurious drugs not only affect the health of the people but also the prestige of Indian’s pharmaceutical trade. The Government of India introduced a whistle blower policy on dealing with spurious drugs (2009). The policy intends to reward both the public and the officials who provide information and help seizure of spurious, adulterated, misbranded drugs, cosmetics and medical devices. It proposed to a maximum of 20 per cent of the total value of seized items limiting the amount not exceeding Rs. 25 lakh for each case. For officials, the reward value does not exceed Rs. 5 lakh in each case limiting the total value of Rs. 30 lakh in full career. Has it been effectively working? Certainly not as so far not a case of whistle blower being awarded!  In the present Ranbaxy’s case the whistle blower would get more than US dollar 48 million.

The pharmaceutical frauds are not new. But, within the US they get caught and in our country they get unnoticed. The pharmas have taken advantage of the laxity of our authorities and continue indulging in cheating and over charging. We do have enough regulations but, there is no a mindset to implement it. What is needed is the exemplary behaviour of the pharmas and eagle eye monitoring of the regulatory authorities to effectively safeguard the interest of ailing communities.