Recognizing drug quality concerns in India signals paradigm shift

New Delhi,  2017:

A common feature in the Government of India's (GoI's) response to any allegation of sub-standard medicines supplied by the Indian industry is to deflect attention by insinuating a "foreign-hand", that foreign governments and their industry conspire to defame the Indian industry because they cannot compete with the Indian pharmaceutical industry.

When the Ranbaxy scandal became public, the Indian government issued a press release saying that "vested interests are raking up isolated issues" and that it had reliable information that the bad press was reflective of "desperate attempts by other countries getting affected by the strength of Indian pharmaceutical industry". Similarly, post the GVK Bio scandal, when the EU scrapped several hundred drug approvals because it had evidence that GVK Bio was fabricating clinical test data, the Drug Controller General of India (DCGI) responded by saying "one must understand that there is a bigger game being played out here. I have repeatedly stated that multinational pharmaceutical companies constantly use incidents like this to bring disrepute to Indian generic drug makers".

Unfortunately, data over the past five years have conclusively proven that there is no foreign hand or that the issue of quality of medicines is isolated; the industry lobby Indian Pharmaceutical Association (IPA) finally admitted that 85 per cent of the drug supply in India has no proven therapeutic efficacy or safety. As to the reliability of the information it claimed, which formed the basis of its proclamations, the administration has never made it public.

Well after years of constant denial, it appears that the Indian government is finally ready to accept that there is a problem with the drugs that are manufactured and sold within India. The Draft Pharmaceutical Policy 2017, prepared by the Department of Pharmaceuticals, has an entire paragraph dedicated to the quality concerns that affect the domestic market. The policy states: "The quality assurance of indigenously manufactured drugs is another area of concern. While the drugs that get exported have a stringent quality assurance system, put in place and insisted by the importing countries internal requirements; concerns have been raised on the quality surveillance of the indigenously manufactured drugs for domestic consumption."

And then it continues to say: "The manufacturing permission for established drugs (already in market for more than 4 years) is given by State Drug Administrators without any bio-availability and bio-equivalence test of the claimed products. The inspection of the manufacturing premise and processes are, many a times, perfunctory or absent. Many manufacturing units are not compliant with the World Health Organization's (WHO) good manufacturing practices (GMP) or the good laboratory practices (GLP). All these severally and in combination give rise to grave quality concerns in pharmaceutical industry."

This acceptance of a reality of our drug supply signals a paradigm shift in the GoI's attitude and should be welcomed. One of the possible reasons that these revelations have been made is because the Department of Pharmaceuticals has not been "captured" by the pharmaceutical industry. The same cannot be said for some other departments, which often act as de-facto spokespersons for the Indian pharmaceutical industry rather than for the country's public health.

The question now is that what exactly does the Draft Pharmaceutical Policy 2017 suggest to improve the quality of drugs in India? The answer is, not very much. The policy does make standard noises about makes quality testing like making bio-equivalence studies compulsory at all levels; this has already been addressed by the health ministry, although in a half-baked manner. On the most important issue of inspection of plants, the policy recommends self-certification, despite the litany of horror stories that we have heard from foreign regulators about poor practices in our pharmaceutical industry. The second aspect proposed by the policy is to ensure that government procurement is done only from manufacturing units that are GMP- and GLP-compliant. But then again, GMP standards are mandatory under Schedule M and GLP standards are mandatory under Schedule L of the Drugs & Cosmetics Act, 1940. This begs the question, why are plants not complying with these standards even operational in India? Unfortunately, the draft policy is silent on the overhaul of the country's regulator whose job is to enforce the law on the books.

The policy is, however, correct in its approach of leveraging India's massive public procurement system to force better quality standards on the pharmaceutical industry. Between the railways, armed forces, government hospitals and Jan Aushadhi stores, the government spends thousands of crores of rupees on purchasing drugs. Each of these procurement agencies individually test consignment of medicines purchased. Such testing generates a very rich data set that can complement the data generated by different state regulators who also test drugs randomly sampled across the market. If these multiple data sets can be converged into one single database that is made accessible to all public procurement agencies whether in the public or private sphere, it would go a long way in helping the state leverage the might of the buyers to blacklist suppliers who manufacture poor-quality drugs. As of today, there is simply no comprehensive mechanism for information sharing between different state regulators, forget different public procurement agencies.

A more comprehensive reform of course requires doing away with the system of different regulators in each state. As one nation and one market, India needs to have one regulator but do not count on that happening anytime soon the pharmaceutical industry and its lobbying power will fight tooth-and-nail to prevent that from happening. The Indian Express