India, the land of diverse cultures, does have a common aspect among all — i.e. our culture of acceptance. As we grow up, we are never encouraged to ask too many questions. Probably, this is well manifested in the current debate over the Ranbaxy drugs in India. Ever since Ranbaxy agreed to pay $500 million to settle US fraud charges and most recently the US FDA imposed a ban on manufacturing and distributing active pharmaceutical ingredients (APIs) from Ranbaxy’s facility in Toansa, Punjab, India, for FDA-regulated drug products, the popular arguments in the debate have been — this being an organized effort by the pharmaceutical industry in the US and other developed markets to malign and pressurize the Indian pharmaceutical industry which produces low priced generic drugs; the other view raising serious doubts over the safety of prescribing such drugs for the Indian patients.
Although the arm-twisting theory does seem convincing given the neo-colonial power structures, this move has implications for more than just the fraught company. To start with, the US FDA (Food and Drug Administration) has also identified “significant violations of current good manufacturing practice (cGMP) regulations” at two facilities belonging to Wockhardt, apart from issuing warning letters to a host of other firms such as Dr Reddy’s, Lupin, Sun Pharma and Aurobindo Pharma. While Ranbaxy may be the only company to have been prohibited from manufacturing drugs from some of its Indian plants for the US market, it’s high time the Indian government and its drug regulatory authorities (CDSCO) wake up to take some action. At stake is India’s $15 billion-a-year pharma exports, over a quarter of which goes to the US. If a company hopes to export to the US, it has no option but to meet the latter’s regulatory requirements, howsoever stringent they may be.
Secondly, regulators from different countries have identified similar violations of cGMP at multiple manufacturing facilities across multiple companies in India. This points towards the existence of a real problem, which needs to be at least recognized by the government, to begin with. A PIL (public interest litigation) filed against selling of ‘adulterated drugs’ in India was rejected by the Supreme Court due to lack of data to prove the accusations (after the company in question paid a fine in the US for the same offence). Yet, no serious systematic inquiry has been made to get to the roots of the issue and to collect the data regarding it.
Thirdly, very surreptitiously, the drugs and quality control standards etc which were inspected and passed by the Central Drug Standards Control Organization (CDSCO) across various firms in India ultimately failed to pass the tests of US FDA. At least the current debate has led to a stir and a public suit has been filed in the Supreme Court asking for reform in India’s drug controller. As a matter of fact, what the US FDA calls “adulterated” drugs includes any medicine not manufactured under conditions confirming to its cGMP regulations — it does not necessarily mean the product is inadequate or ‘substandard’.
All this together point to the immediate need for an analysis of our own quality controls in drugs manufacturing. To move out of our shells and ask the right questions. The focus right now ought to be to create systems that capture data about the quality of our drug supply first, together with better structured and transparent institutions for drugs control in India.