Rx: A Good Doctor to Treat the Ailing Pharma Sector
An open letter to PM Narendra Modi for an effective drugs regulator to revive the sector
Dear Prime Minister, ike millions who hope your leadership can propel our country toward prosperity, I too was glued to the television to hear your victory speech. I was heartened to hear your appeal to the residents of Varanasi to collectively pledge to clean up the streets of the city; to restore the city to its past glory. That you chose personal hygiene and public health as your first objective is compelling.
Public health has never received the same attention as monetary health in India. For a country of over a billion people, we have historically done a poor job of providing effective services in delivery of healthcare. Ensuring effective regulation in healthcare is as important as your call for individual responsibility for personal hygiene. They are two sides of the same coin of a cohesive public health policy.
The laws governing the pharmaceutical industry in India are colonial. The Drugs and Cosmetics Act (1940) and the Rules (1945) are still applicable today. Later amendments — the most recent was in 2005 — have weakened the law and patient safety, than bring it up to global standards.
There are also major, intentional gaps. The Central Drugs Standard Control Organisation (CDSCO) regulates “new drugs”, but the legal definition of “new drugs” excludes new generic medicines (Rules, s. 122E). CDSCO has jurisdiction over “new drugs” for just four years from their approval; who, if anyone, regulates them after four years is not really clear. Medicines that are not “new drugs”, such as new generic versions of old drugs, are never under CDSCO jurisdiction; they are regulated by individual states. These individual states have constitutional jurisdiction to license manufacturing facilities, monitor products and prosecute violations.
Imports and safety of drugs for domestic consumption is the remit of the CDSCO. But its role over drug exports is that of a Potemkin regulator: it signs off on export licences, while allowing drug firms to self-assess their compliance. CDSCO claims these medicines meet the World Health Organization (WHO) standards for Good Manufacturing Practices (GMPs), but it does not really know, and has no apparent legal basis for this responsibility.
CDSCO, located within the ministry of health and family welfare, prescribes standards for ensuring safety, efficacy and quality of drugs; it regulates market authorisation of new drugs and clinical studies, supervises drug imports and approves licences to manufacture new drugs. The ministry of commerce and industry promotes the Indian pharmaceutical industry, but it doesn’t have any knowledge of the quality of products it promotes. The National Pharmaceutical Pricing Authority (NPPA), under the department of chemicals and petrochemicals, establishes prices of drugs and enforces availability of medicines in the country. It is hardly a surprise that the industry has difficulty in dealing with such a disjointed, bureaucratic system.
Lack of a coordinated regulatory framework has a direct bearing on limiting the growth of this industry. Delays in securing regulatory approvals to conduct clinical studies in the country is forcing the industry to spend a lot more money to conduct these studies overseas. A kneejerk reaction against enforcement of global manufacturing standards to ensure product quality is eroding the credibility of the industry. A schizophrenic policy that governs local pricing and global investments provides no assurance to the industry of stable and sustainable policies leading to muted growth.
The industry’s exports, driven primarily by the advantage of lower cost of manufacturing and skills in process and medicinal chemistry, have been tainted by a few who took advantage of the fragmented regulatory structure to put profits before the hopes of the sick and poor. As a result, those very products that are enjoined from export to markets where regulatory mechanism is effective make their way into the domestic market and are consumed by India’s poor.
The Way Forward
Your party’s manifesto recognises this situation. It pledges to reorganise the ministry of health and family welfare for effective delivery of healthcare services. With a massive mandate for change and better governance, there is no better time than now to make this happen.
In 2003, the Mashelkar Commit- tee Report recommended establishment of a National Drug Authority to restructure this disjointed regulatory framework. Unfortunately, many of the recommendations made by this committee were never been seriously considered and even fewer adopted. Clearly, individual states have vested interests in the current structure. As a former chief minister, no one is better positioned than you to understand Centre-state dynamics. We need an innovative mechanism to resolve this impasse.
There have been some attempts to remedy this situation in the recent past. Increasing the budget for the CDSCO from a meagre .` 24 crore annually to around .` 3,000 crore over five years is a good start. But we need structural reforms. The role of the Drug Controller General of India (DCGI) needs to be elevated to an independent executive level. It doesn’t have any statutory power over state regulatory machinery now. It reports to a joint secretary in the ministry of health, three levels removed from the decision makers.
It is instructive to compare the regulators for pharmaceutical and telecommunications, two industries that are similar in size. The Telecom Regulatory Authority of India (Trai) has been instrumental in ensuring access to low-cost, good quality communication services reaching even the most remote parts of our country. Sadly, the pharmaceutical industry doesn’t have a regulator of Trai’s stature, and it shows.
The industry earns more selling its products overseas than it does in locally. One complaint I hear most from our global customers is the lack of competence and credibility of the Indian regulator. As someone who has recently led a progressive and message-oriented campaign, you must recognise that credibility of the leadership is instrumental in realising the impact of the message. Our regulator needs to speak effectively for public health in India and for the policies of your government in a credible manner to the global community. We need someone who is not just technically qualified — a medical doctor, someone who has worked in the industry to bring new drugs to the market, someone who understands the expectations and has worked with global regulators, someone who was responsible for innovation — but someone with unimpeachable integrity.
The mandate you received was in response to your vision of good governance and a responsive administration. Help us create an environment where the global pharmaceutical industry engages more productively in India rather than shipping its research and development and manufacturing facilities to China. Restore the credibility of this industry allowing it to fulfil the promise of thousands of well-paying jobs to the young people here. Make public health a priority for your administration; and help realise the hopes and dreams of a clean and healthy India.