Wednesday, June 5, 2013

Murky Tale of Indian Pharma Industry

 Ranbaxy and US FDA

If the reports are to be believed, Ranbaxy Laboratories Ltd, the country's largest drug maker, is reported to have agreed to pay $500 million fine to US Authorities after pleading guilty to "felony charges" for making and selling adulterated drugs,  to settle civil and criminal charges of making fraudulent statements to the US Food and Drug Administration (FDA).

 Ranbaxy is also reported to have falsified data to secure FDA approvals, while systematically violating the Agency's Current Good Manufacturing Practices (cGMP) and good Laboratory Practices, resulting in sub-standard or unapproved drugs.


Good Manufacturing Practice Regulations


 The Good Manufacturing Practices (cGMP) Regulations enforced by the US FDA provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities.  If a Pharma Company is not complying with cGMP regulations, any drug it makes is considered "adulterated" under the law.  This kind of adulteration means that the drug was not manufactured under conditions that comply with cGMP. It does not mean that there is necessarily something wrong with the drug.


Even if the drugs are not defective, FDA can bring a seizure or injunction case in court to address cGMP violations.   When FDA brings an injunction case, FDA asks the court to order a company to stop violating cGMP. Both seizure and injunction cases often lead to court orders that require companies to take many steps to correct cGMP violations. The FDA can also bring criminal cases because of cGMP violations, seeking fines and jail term.

Seriousness of Pollution Problems

The seriousness of the pollution problem from the Bulk Drug industries at Pattancheru near Hyderabad was highlighted in 2007, by an environmental scientist of Sweden, when he found at Pattancheru Effluent Treatment Ltd (PETL), the discharge load of Ciprofloxacin, corresponding to approx. 45 kg of active ingredient per day. It is likely to raise antibiotic bacterial resistance in the world, making it a Global Concern.   


 In addition to Ciprofloxacin, the supposedly treated effluents of PETL had 21 different active pharmaceutical ingredients, used in generics for treatment of hypertension, heart disease, chronic liver ailments, depression, gonorrhea, ulcers and other ailments. It was reported that half of the drugs detected were at the highest levels of pharmaceuticals ever detected in the environment.  In economical terms, if the equivalent amount of the 11 most abundant active substances released by PETL during 24 hrs were to be purchased as final products in a Swedish pharmacy; they would cost over 100,000 British Pounds.


 Non Compliance, High-Profit Business in India


 The non-compliance of Pollution Control Rules & Regulations, particularly for the Bulk Drug Units, has become a high-profit business, because of laxity/collusion on the part of the regulating agencies and/or the political interferences. As a result, the Indian Bulk Drug products have become very competitive in the international markets, as the costs of treating the pollutants / complying with cGMP Regulations, are avoided through externalizing pollution / impacts by passing them on to the society.


The AP Pollution Control Board which is engaged in a loosing battle with Bulk Drug units for over 2 decades, is reported to have identified 57 Pharma units out of 98 operating in Medak District and 33 out of 66 in RR District, producing the un-consented products or excess production more than the permitted capacity in utter disregard to Rule of Law and the Ban Order issued in compliance with Supreme Court directive. 


 Instead of initiating stringent penal action under Section 15 of Environment (Protection) Act, 1986, the APPCB Board seems to be finding ways and means for bailing out the offending Bulk Drug Units. The Board which is constituted as statutory body to work within the frame work of the statutes, Water Act, Air Act, Environment Act etc. seems to have become an extension or appendage of Department of EFS&T/ Govt of AP/BDMA. 




These Bulk Drug Industries contaminating the Air, the Water and the Soil, are committing Environmental Crimes that often damage the community more seriously than the Criminal Offence of the conventional kind. The Industry, setting aside their "Corporate Social Responsibility" is willing to take the risk to the bitter end, until it is no longer possible to conceal & fool around and till it economically hurts.


Therefore, the facts of the Crime have to be revealed, and the culprits have to be named, booked and penalized, so that it hurts them economically and socially. They will have to be penalized like the hard core criminals. Can we expect this to happen in our present system of Governance or do we need the intervention of US FDA?