For Drug Safety Concern: “Whistleblower’s Intention Should Be Nationalistic”

Posted on March 14, 2016 by Tapan Ray

In the recent weeks, three significant developments related to the Pharmaceutical Industry in India, have triggered rejuvenated concerns in the following critical areas:

A. Overall drug safety standards in the country

B. Self serving interest, rather than patients’ interest, dominate the prescribing decisions

C. Government assurance to American Trade Organization on ‘Compulsory License (CL)’ in India.

These important issues fall under three key regulatory areas of India, as follows:

The Central Drugs Standard Control Organization (CDSCO)
The Medical Council of India (MCI)
The Indian Patent Office

It is worth mentioning here that the Department Related Parliamentary Committee on Health and Family Welfare in its 59^th Report, placed before both the houses of the Parliament on May 08, 2012, on the functioning of the Central Drug Standards Control Organization (CDSCO), begins with the following observations:

Medicines apart from their critical role in alleviating human suffering and saving lives have very sensitive and typical dimensions for a variety of reasons. They are the only commodity for which the consumers have neither a role to play nor are they able to make any informed choices except to buy and consume whatever is prescribed or dispensed to them, for the following reasons:

Drug regulators decide which medicines can be marketed
Pharmaceutical companies either produce or import drugs that they can profitably sell
Doctors decide which drugs and brands to prescribe
Consumers are totally dependent on and at the mercy of external entities to protect their interests.

Most importantly, all these concerns, if not properly clarified and appropriately addressed by the Government, soon enough, have the potential to create an adverse snowballing impact on the uniform access to affordable quality medicines, for all sections of the society in India.

Under this backdrop, I shall discuss in this article briefly, my perspective on each of these critical areas, as they are today, and not just the drug safety concerns.

The headline of this article is expected capture not only the prevailing mood of some key regulators, but also their inertia to address critical healthcare concerns and above all how the core public health related issues are getting lost, and the trivial ones are gradually occupying the center stage.

A. Overall drug quality and safety  standards in India:

A Public Interest Litigation (PIL) suit, filed against the Drugs Consultative Committee and the Central Drugs Standard Control Organization (CDSCO), was listed on the Supreme Court website for hearing on March 11, 2016.

The PIL has been filed by one Dinesh Thakur, requesting the Supreme Court to lay down guidelines by which manufacturers could be made liable for violating drug standards and also give a direction to the government to set up a ‘Drug Approvals Review Committee’ for examining criminality in the manner in which faulty drug approvals were granted.

Many may recall that the same Dinesh Thakur worked for Ranbaxy from 2003 for two years, and is now the Chief Executive of MedAssure Global Compliance based in Florida, US. Thakur’s Company now advises pharma manufacturers on drug safety and quality standards.

As reported by Reuters, Thakur had earlier exposed how the erstwhile largest drug maker of India, Ranbaxy Laboratories, failed to conduct proper safety and quality tests on drugs and lied to regulators about its procedures. Consequently, USFDA fined Ranbaxy US$500 million for violating federal drug safety laws, and making false statements to the US regulator.

This news report further states: “Indian Parliamentary Committee, thereafter, reportedly demanded an investigation and the drugs regulator committed to one in 2013. Thakur received a statement from the health ministry last year, seen by Reuters, showing no inquiry had begun.”

On the last Friday, however, the Supreme Court of India refused to entertain this PIL of Dinesh Thakur, saying it does not have time to adjudicate academic issues, such as, need for guidelines to regulate quality of medicines.

The core issue:

The core issue here is not at all the above PIL, not at the very least. The issue is the much reported concern being expressed, over a period of time, regarding the drug safety standards in India. The reasons include breach of of data integrity, and gross violation of the ‘Good Manufacturing Practices’ standards. Such instances are being detected, almost regularly, by the foreign drug regulators, in several manufacturing facilities run by many large and small Indian drug producers.

It is well vindicated by the fact that around 45 Indian drug manufacturing plants have been banned by the USFDA alone, from shipping generic drugs to the United States, as these were considered unsafe for consumption of patients in the US. Some other foreign regulators too had taken similar action, citing similar reasons. The USFDA website specifies the details of gross violations made in each of these cases.

Ironically, all such facilities can manufacture and sell their drugs in India, as they conform to the quality requirements of the Indian drug regulator. Consequently, the Indian patients consume even those medicines, which are considered unsafe by the USFDA for American patients, innocently, as and when prescribed by the doctors.

Arising out of these incidents, when asked about the drug safety standards in India, and the public health-safety, instead of giving credible and action oriented answers for public reassurance, some of the apparently brazen replies of the DCGI are quite stunning for many stakeholders, both within and outside the shores of India.

I would now quote below just a few of those replies, just as examples.

“…Whistleblower’s Intentions Should Be Nationalistic” - DCGI:

According to Reuters, it has received the following response from the Drug Controller General of India (DCGI), on the above PIL related to the drug safety standards in India:

“We welcome whistleblowers, we have got great respect, but their intentions should be genuine, should be nationalistic… I don’t have any comment on this guy.”

Thus, many industry watchers feel that in a situation like this, the honorable Supreme Court of India would possibly require to intervene, just as what it did on alleged ‘Clinical Trial’ malpractices in the country or for drug price control, solely for public health interest.

The same attitude continues:

Such brazen response of the Central Drug Regulator, and that too on a serious subject, is indeed bizarre. It becomes increasingly intriguing, as the same attitude continues without any perceptible meaningful intervention from the Ministry of Health.

For example, on February 22, 2014, in the midst of a more intense scenario on a similar issue, instead of taking transparent and stringent measures, the DCGI was quoted by the media commenting:

“We don’t recognize and are not bound by what the US is doing and is inspecting. The FDA may regulate its country, but it can’t regulate India on how India has to behave or how to deliver.”

On February 26, 2014, presumably reacting to the above remarks of the DCGI, the American Enterprise Institute reportedly commented, “Indian drug regulator is seen as corrupt and colliding with pharma companies…”

Such apparently irresponsible and loose comments keep continuing, despite the 2012 report of the Parliamentary Committee of India alleging collusion between some pharmaceutical companies and officials of the CDSCO, which oversees the licensing, marketing and trials of new drugs. The report also commented that the agency is both chronically under-staffed and under-qualified.

Some possible remedial measures:

As the saying goes, “better late than never”, considering all these continuing developments, it is about time to reconsider some of the key recommendations of Dr. R. A. Mashelkar Committee on a similar subject and make amendments in the relevant Act accordingly, soon, to facilitate creation of a robust with high accountability ‘Central Drugs Authority (CDA)’. It would introduce a centralized licensing system for drug manufacturing, along with stringent drug safety standards; besides, sale, export and distribution of drugs. Perhaps, the draft bill on CDA is now lying in the heap of archival documents with the change in Government.

Why does India need CDA?

I believe, the formation of a robust CDA with high accountability, besides meeting with drug safety concerns, would provide the following significant benefits, both to the Industry and also to the Government:

Achieving uniform interpretation of the provisions of the Drugs & Cosmetics Act & Rules
Standardizing procedures and systems for drug control across the country
Enabling coordinated nationwide action against spurious and substandard drugs
Upholding uniform quality standards with respect to exports to foreign countries from anywhere in India
Implementing uniform enforcement action in case of banned and irrational drugs
Creating a Pan-Indian approach to drug control and administration
Evolving a single-window system for pharmaceutical manufacturing and research undertaken anywhere in the country.

B. Self serving interest dominates the prescribing decision:

That the self serving interest, rather than patient interest, dominate the prescribing decision, was vindicated by a key announcement of the Medical Council of India (MCI) last month.

In February 2016, apparently succumbing to continuous and powerful external pressure, the MCI announced an amendment in a clause of its Code of Ethics Regulations 2002, exempting doctors’ associations from the ambit of its ethics code, as applicable to doctors now across the country. Prior to the amendment, this section used to read as: “code of conduct for doctors and professional association of doctors in their relationship with pharmaceutical and allied health sector industry”.

In other words, it means that the professional associations of doctors will no longer come under the ambit of ethics regulations, legitimizing their indulgence in the identified unethical and corrupt practices, by receiving gifts in cash or kind from the pharma or healthcare industry.

A large section of the key stakeholders believes that this amendment would help creating an additional large space for the pharmaceutical marketing malpractices to thrive, unabated, at the cost of patients.

The latest report of the Parliamentary Standing Committee on MCI:

In its 92nd Report, the Department-Related Parliamentary Standing Committee on Health and Family Welfare titled, “The Functioning of Medical Council of India”, presented to the Rajya Sabha and laid on the Table of Lok Sabha on 8th March, 2016, the Committee observed on this amendment as “an action that is ethically impermissible for an individual doctor cannot become permissible, if a group of doctors carry out the same action in the name of an association.”

The report also noted the failure of MCI to instill respect for a professional code of ethics in the medical professionals and take disciplinary action against doctors found violating the code of Ethics, etc.

The Committee called for a complete restructuring of the MCI, since it believes that the Council has failed as a regulator of medical education and the profession. Casting serious aspersions on the functioning of the MCI, the house panel of the Parliament recommended that the Act under which the MCI was set up be scrapped and a new legislation be drafted “at the earliest”.

The report castigated the health ministry:

The lawmakers castigated the Health Ministry in this report saying, “The committee also finds it intriguing that instead of intervening to thwart attempts of MCI at subverting the system, the ministry meekly surrendered to MCI.”

While summing up, the report states, “the Committee exhorts the Ministry of Health and Family Welfare to implement the recommendations made by it in this report immediately and bring a new Comprehensive Bill in Parliament for this purpose at the earliest.”

How will it pan out now?

I reckon, it will now be immensely interesting now for all concerned to follow, how does the Government deal with this report to curb, among others, the strong interference of mighty and powerful vested interests to continue with the rampant pharma marketing malpractices, at the cost of patients in India.

C. Reported Government assurance on ‘Compulsory License’:

On March 3, 2016, a media report quoted a submission by the US Chamber of Commerce to the office of the US Trade Representative (USTR) as follows:

“While the Government of India has privately reassured (American) industry that it would not use compulsory licenses for commercial purposes, a public commitment to forgo using (this) would enhance legal certainty for innovative industries.”

This is an interesting development, primarily because there are a number of legal provisions for granting Compulsory Licenses (CL) in the Indian Patents Act 2005, including, when a drug is not widely available, extremely expensive and some other situation. In some these provisions, law should follow its own course and there is no legally permissible scope for Government’s administrative interference. Grant of CL for Nexavar of Bayar is one such example, and incidentally, that’s the sole CL that India has granted, so far, from the date of amendment of the country’s Patents Act in 2005.

Thus, a blanket assurance of not invoking any of the provisions of the CL, as provided in the Indian Patents Act 2005, if true, would possibly require to pass through intense legal scrutiny, as that would adversely impact the access to key medicines in a necessary situation, for the public health interest.

So far, India has amply demonstrated to all, time and again, that the country does not grant a CL at the drop of a hat. That situation should continue to encourage and protect innovation.

Nevertheless, “a written public commitment to forgo using the CL provisions for enhancing legal certainty for innovative industries,” as demanded by the US Chamber of Commerce, appears to be unreasonable, goes against the spirit of India’s Patents Act, and perhaps is not legally tenable either, unless the IP Act is amended accordingly in the Parliament.

Conclusion:

All these three areas, as discussed above, are critical from the healthcare perspective of the country.

Ironically, while deliberating on the subject, the capability, credibility and competence of some of the key regulators of the country, are being repeatedly questioned. These doubts emanate not just from Tom, Dick and Harry, but from an illustrious spectrum of constitutional institutions of India, spanning across the lawmaking Parliament, through its various committee reports, to the ultimate legal justice provider – the Supreme Court of India, through is various orders and key observations.

Regrettably, in this specific space, which is primarily related to healthcare, nothing seems to be changing on the ground, since long. The same tradition continues, without any visible sense of urgency, even from the Government.

On the contrary, we now read a new genre of comments, even from a key regulator, on the stakeholder concerns. For example, reacting to concern on drug safety standards, instead of articulating tangible actions to usher in a perceptible change, the chief action taker reportedly specified a totally judgmental and an outlandish requirement: “…Whistleblower’s intentions should be Nationalistic.”

Together with these incidents, the key public healthcare concerns of India too, are now apparently getting drowned in the high decibel ‘Nationalistic’ versus ‘Anti-nationalistic’ cacophony. But, the hope still lingers… for a change…for our nation’s sound health!

By: Tapan J. Ray

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

Quick implementation of the undiluted ‘Central Drug Authority (CDA)’ Bill is essential for emerging India

Posted on February 21, 2011 by Tapan Ray

Many industry experts after having evaluated the provisions of the original draft proposal for forming a Central Drugs Authority (CDA) in the country, commended and supported this laudable initiative of the Government. This Bill also known as, “The Drugs & Cosmetics (Amendment) Bill No.LVII of 2007 to amend the Drugs & Cosmetics Act, 1940” was introduced in the ‘Rajya Sabha’ on August 21 2007 and was thereafter referred to ‘The Parliamentary Standing Committee of Health and Family Welfare’ for review. The Committee also has submitted its recommendations to the Government since quite some time. However, the fact still remains that the proposed CDA Bill has not seen the light of the day, as yet.
Mashelkar Committee Recommendation:
It is high time to consider the recommendations of Dr. R.A. Mashelkar Committee on the subject and make amendments in Act to facilitate creation of a Central Drugs Authority (CDA) and introduce centralized licensing for manufacturing for sale, export and distribution of drugs.
Seven reasons for the dire need of the CDA in India:
I firmly believe that the formation of the ‘Central Drugs Authority (CDA)’ will provide the following benefits to the Industry and also the Government:
1. Achieving uniform interpretation of the provisions of the Drugs & Cosmetics Act & Rules
2. Standardizing procedures and systems for drug control across the country
3. Enabling coordinated nationwide action against spurious and substandard drugs
4. Upholding uniform quality standards with respect to exports to foreign countries from anywhere in India
5. Implementing uniform enforcement action for banned and irrational drugs
6. Creating a pan-Indian approach to drug control and administration
7. Evolving a single-window system for pharmaceutical manufacturing and research undertaken anywhere in the country.
Major countries have similar set up even within a federal system:
All major countries of the world have a strong federal drug control and administration system in place for the Pharmaceutical Industry. Like for example, despite strongly independent states within the federal structure of the U.S., the US – FDA is a unified and fully empowered federal government entity.
Similarly, coming together of many independent countries in Europe had led to the need for a pan-European drug control agency. This responsibility was vested on to the ‘European Medicine Agency (EMEA)’ with overriding pan-European authority and powers within the European Union (EU).
Thus, a single Central Authority that administers and regulates both pharmaceutical manufacturing and research is an absolute necessity in India’s bid to be a global hub for drug discovery.
The interim measure:
In my view, till CDA is formed, registration and marketing authorization for all new drugs and fixed-dose combinations should only be granted by Drugs Controller General of India (DCGI). I would emphasize, it is essential that a smooth transition takes place from the existing regulatory environment to the proposed CDA, carefully tightening all the loose knots in the process. All necessary infrastructures along with the required personnel must be in place, so that all permissions are granted to applicants within stipulated timeframe.
The watershed regulatory reform initiative should not get diluted:
The CDA Bill is widely considered as a watershed regulatory reform initiative in the pharmaceuticals space of India. This reform process, besides offering all other benefits as discussed above, would also be able to update the legislation, considering significant advances the country has made since the last five decades, especially in the areas of clinical research, treatment methods, and sophisticated diagnostic and medical devices.
Conclusion:
It now appears, the Government could revive the CDA Bill and reintroduce it in the Parliament, sooner. It was to be introduced in its monsoon session. However, the plan did not fructify, as the Parliament could not function due to a logjam created by our politicians.
It is worth noting that the proposed centralize drug licensing mechanism was vehemently opposed by the state drug authorities and some section of the industry. The stated position of the opponents to the CDA Bill apprehends that the centralized structure will not be able to deliver, as the requisite infrastructure and manpower for the same are not in place, as yet.
This development bring out to the fore the lurking fear that the proposal to centralize drug licensing as a part of the proposed law, very unfortunately, may eventually get quite diluted because of vested interests.

By: Tapan J Ray

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

Quick implementation of the UNDILUTED ‘Central Drug Authority (CDA)’ Bill is essential for emerging India

Posted on January 31, 2010 by Tapan Ray

Many industry experts after having carefully evaluated the provisions of the original draft of the proposal of forming a CDA in the country commended and supported this praiseworthy initiative of the Government. This Bill also known as, “The Drugs & Cosmetics (Amendment) Bill No.LVII of 2007 to amend the Drugs & Cosmetics Act, 1940” was introduced in the ‘Rajya Sabha’ on August 21 2007 and was thereafter referred to ‘The Parliamentary Standing Committee of Health and Family Welfare’ for review. The Committee also has submitted its recommendations to the Government since quite some time. However, the fact still remains that the proposed CDA Bill has not seen the light of the day, as yet.

Mashelkar Committee Recommendation:

It is high time to consider the recommendations of Dr. R. A. Mashelkar Committee on the subject and make amendments in the Act to facilitate the creation of a Central Drugs Authority (CDA) and introduce centralized licensing for the manufacture for sale, export or distribution of drugs.

Seven reasons for the dire need of the CDA in India:

I firmly believe that the formation of the ‘Central Drugs Authority (CDA)’ will provide the following seven significant benefits to the Industry and also to the Government:

1. Achieving uniform interpretation of the provisions of the Drugs & Cosmetics Act & Rules

2. Standardizing procedures and systems for drug control across the country

3. Enabling coordinated nationwide action against spurious and substandard drugs

4. Upholding uniform quality standards with respect to exports to foreign countries from anywhere in India

5. Implementing uniform enforcement action in case of banned and irrational drugs

6. Creating a pan-Indian approach to drug control and administration

7. Evolving a single-window system for pharmaceutical manufacturing and research undertaken anywhere in the country.

Major countries have similar set up even within a federal system:

All major countries of the world have a strong federal drug control and administration system in place for the Pharmaceutical Industry. Like for example, despite strongly independent states within the federal structure of the U.S., the US – FDA is a unified and fully empowered federal government entity.

Similarly, the coming together of many independent countries in Europe has led to the need for a pan-European drug control agency and that responsibility has been vested on the ‘European Medicine Agency (EMEA)’ which has overriding pan-European powers, that is within the European Union (EU).

Thus, a single Central Authority that administers and regulates both pharmaceutical manufacturing and pharmaceutical research is an absolute necessity in India’s bid to be a global hub for drug discovery.

The interim measure:

In my view, till CDA is formed, registration and marketing authorization for all new drugs and fixed-dose combinations should only be granted by Drugs Controller General of India (DCGI). I would like to emphasize, it is essential that there a smooth transition takes place from the existing regulatory environment to the proposed CDA, carefully tightening all the loose knots in the process. All necessary infrastructures along with the required personnel must be in place so that all permissions are granted to applicants within stipulated time frame.

The watershed regulatory reform initiative should not go waste:

Thus the CDA Bill is considered to be a watershed regulatory reform initiative in the pharmaceuticals space of India. This reform, besides all others as discussed above, would have updated the legislation considering the advances the country has made, especially, in the last five decades in clinical research, treatment methods, and sophisticated diagnostic and medical devices.

Conclusion:

It now appears that the Government could revive the CDA Bill and reintroduce in the Parliament. It was to be introduced in its monsoon session. However, the plan did not fructify because of various political reasons.

Centralize drug licensing has also been highly opposed by the state drug authorities and some section of the industry. The stated position of these opponents to the CDA Bill highlights that the proposed centralized structure will not be able to deliver as the requisite infrastructure for the same is not in place, as yet.

All these developments bring out the apprehension that the proposal to centralize drug licensing as part of the proposed law, very unfortunately, may get quite diluted because of vested interests.

By Tapan Ray

The Professor, Counterfeit Drugs, CDA Bill and the New Health Minister

Posted on June 4, 2009 by Tapan Ray

Just a couple of days ago, I met Professor Sam Gupta, an American professor of Indian origin. Prof. Gupta has specialized in nuclear medicine and hails from a well reputed North American University. Dr. Gupta, like many others, had left the shores of India decades ago when he was just a student. During his long arduous journey on the beaten path of life, he almost lost contacts with his roots in India.

An incident that triggered intense passion in Prof. Gupta:

When I met him just the other day, I heard him passionately speaking about the menace of substandard and counterfeit medicines, in the world in general and India, in particular. He was reminiscing how had he decided to wage a war, as it were, against this injustice against humanity. Despite having a nuclear medicine background, Prof. Gupta is fighting this crusade against evil with an intense passion, as intense as it could possibly be.

The professor still teaches and researches on nuclear medicine in North America… but he spends all his balance time driven by this passion, to bring home some change in the uncertain treatment environment, involving well being of a large number of patients, especially in India. What then triggered this ‘burning desire’ in the mind of a seemingly quite and extremely polite Prof. Gupta?

Not a very long ago, a person, very dear and near to the professor, while visiting India became a tragic victim of a counterfeit medicine. Professor lost his dear one, in India. Intense sadness due to loss of this otherwise healthy individual, that too so suddenly, got converted into a potent rage in him… and… the rage into a passion… a passion to stop the menace of substandard and counterfeit medicines, in whatever way he possibly can.

Professor’s dear one is not the sole victim of spurious, substandard and counterfeit medicines in India. Such tragedy strikes many hundreds and thousands of Indians every year. We come to know very seldom and very little about such instances, for various reasons. Real reasons of most of these tragic deaths, usually remain unknown to the civil society, at large… but the ‘merchants of death’ keep making fast bucks with their cash counters constantly ringing. Heart rending cries for loss of human lives, because of their mischief, do not mean anything to them. To the regulators, ironically, price of medicines appears to be more important than the quality of medicines.

Minimum acceptable quality standards for medicines:

Though medicines should offer and promise maximum possible quality standards, in India we are satisfied with the ‘minimum acceptable quality standards’ even for medicines and of varying degree of quality, just as any other commodities. It is not unknown to many that in India, we have broadly two types of quality – one type of quality exists for the domestic consumption and use and the other type of quality is for people living outside India and mainly in the western world, which is termed as ‘exports quality’. ‘Exports quality’ products attract a premium in India to the common man, even in the 21st. century.

Varying degree of acceptable drug quality in India:

Just like ‘domestic’ and ‘exports’ quality, for medicines we have many acceptable quality standards, in India: GMP quality, WHO GMP quality, US-FDA quality just to name a few. It appears that our regulators are just satisfied in ensuring availability of cheaper priced medicines with ‘minimum acceptable’ or ‘varying’ quality standards. If not, why is there no concerted effort by the drug regulator to strike at the root cause of proliferation of substandard and counterfeit medicines in India? When we see so many regulators working so well to ensure ‘affordability’ of medicines, why is the drug regulator failing to stop proliferation of substandard and counterfeit medicines in the country, in a systematic way? Who is accountable, when a patient takes affordable medicines of poor quality and suffer from undesirable consequences? Some estimates indicate that at least 10% of medicines produced in India are substandard.

Some good initiatives were implemented and some equally good initiatives were stalled – why?

A major amendment in the Drugs & Cosmetics Act, 1940, proposed in October 2007 and enacted into a law in 2008, has increased the minimum jail term for counterfeit drug offenders from 5 to 10 years and the minimum fine for such offenses increased from Rs. 10,000 (about U.S$ 220) to Rs. 10 lakh (about U.S$ 22,000).

However, the amendment of the Drugs & Cosmetics Act, 1940 to create a Central Drug Authority (CDA) has not seen the light of the day, as yet, due to various vested interests. The CDA, if created, would have been responsible for the entire drug regulatory mechanism in India including all marketing approvals and uniform quality standards of medicines, across the country.

What happens today for manufacturing and marketing approval of drugs in India?

Currently, although the Drug Controller General of India (DCGI) gives marketing approval of all new drugs, imported or domestic, the manufacturing permission of these drugs in India is granted by concerned state drug regulatory authorities. It is believed that there is a perceptible variation within the states in quality of inspection, monitoring and enforcement of various regulatory systems and maintenance of uniform drug quality standards.

It is worth noting that ‘new drug’ status of a formulation type, remains for four years. After this period the state drug authorities can grant marketing approval of such products. Huge regulatory quagmire created with unabated proliferation of Fixed Dose Combination products (FDC) in India, is a testimony of how the drug regulatory systems works in India.

Despite existence of such variation in standard from state to state, it is indeed an irony that drugs approved and produced in any state are allowed to be marketed and sold across India or even be exported outside the country. It is quite possible that substandard drug producers can locate themselves in states with weaker regulatory controls and make their cheaper substandard products available for sales across the country, making hundreds and thousands of innocent citizens vulnerable to a possible life threatening risk.

Drug regulatory mechanism deserves a revamp in India without further delay:

Some people believe that hectic efforts by politicians and vested interests from the states with weaker regulatory controls have prevented the CDA bill from getting translated into reality, showing scant respect to the need of patients who may not have any other option but to use these substandard drugs.

How does the western world care for their patients with high quality medicines?

In the western world, drug regulators have taken specific measures to ensure availability of highest quality of medicines for their citizens. It is for that reason Food and Drug Administration of the United States of America (US-FDA) has opened its establishment in India to ensure that the drugs, which are manufactured in India and exported to the USA, are of highest quality standards.

Lackadaisical approach of the Indian drug regulatory authorities has created an environment within the country where many pharmaceutical manufacturers, including some large ones have allegedly placed themselves in a peculiar ‘comfort zone’ by not following prescribed procedures of generating required essential documents, while manufacturing drugs of high quality standards.

Continuous living in such comfort zones led to the largest pharmaceutical company of India, facing ban of 30 of their product formulations in the USA in 2008, against the charge of ‘falsifying’ the product manufacturing documents – a stigma on the pride of India in general and the Indian pharmaceutical industry, in particular, which will remain till the issue is sorted out. As if this was not enough, close on its heel some more incidents came into light with the names of other top Indian companies falling under the scanner of US FDA for not conforming to their regulatory requirements related to drugs manufactured for use in the US market.

When regulators of other countries are so active, why then are our own drug regulators failing to clean up the menace of spurious, substandard and counterfeit medicines in India? Why important bills like CDA are being stalled by the vested interests with the help of politicians, exposing a large number of patients to medical risks?

Will the new government be any different?

I sincerely hope that our new Minister of Health, Shri Ghulam Nabi Azad will sincerely address this very pressing health issue for the country. I also believe that under his astute leadership, the menace of spurious, substandard and counterfeit medicines will receive due consideration of the cabinet and the CDA bill will soon be a law.

Till then…crusade of Prof. Gupta continues:

If it happens, just as Dr. Gupta, the Indian American professor of Nuclear Medicine will get a huge sense of accomplishment, after fighting a long and arduous battle to save patients from the danger of substandard and counterfeit medicines in India, the civil society of our country will at the same time feel a unique sense freedom… the freedom from fear… the fear of substandard and counterfeit medicines.