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Drugs From The Same Indian Plant: Safe For Europe, Unsafe For America, Why?

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Good number of stories on US-FDA banning several drug manufacturing facilities of major domestic players of India over serious quality related issues, have been doing the rounds since about a year and almost at a regular interval.

The quagmire has snowballed into serious apprehensions on the quality of Indian generic drugs, across the globe. Various statements of US-FDA Commissioner Margaret Hamburg, during her much talked about maiden visit to India, in February 2014, added further credence to the issue.

“If you want our market, meet our standards”:

During Hamburg’s India visit, her reported candid warning to the Indian drug exporters to America added further fuel to the above concern in India. She clearly underscored:

“If you want our market, meet our standards.”

Even in the face of this stern warning, when major drug manufacturers of India, such as, Ranbaxy, Wockhardt, Sun Pharma and some others continued to fail in meeting US-FDA drug quality standards in their respective plants, I wrote the following in one of my earlier blog posts titled, “Does India Believe in Two Different Drug Quality Standards?”:

“In a situation like this, especially when many Indian manufacturers are repeatedly failing to meet the American quality standards, the following questions come up:

  • Is the US-FDA manufacturing requirement too troublesome, if not oppressive?
  • If not, do the Indian and other patients too deserve to have drugs conforming to the same quality standards?

Answers to these questions are absolutely vital to convince ourselves, why should Indian patients have access to drugs of lower quality standards than Americans, with consequential increase in their health risks?”

The first question on ‘troublesomeness’ now partly answered?

This is because another recent media report brought to the fore that, having completed their assessment of drug manufacturing violations at Ranbaxy’s facility in Toansa, European regulators have said although deficiencies were found, they pose no risk to public health. The regulators said they were satisfied by corrective measures put in place by the company after U.S. regulators found deviations in January.

The report also highlights that this assessment of the European regulators stands in stark contrast to the response of US regulators to the deficiencies found at the same plant.

It is worth noting that US-FDA continues to restrict Ranbaxy from making and selling pharmaceutical ingredients from the Toansa facility “to prevent substandard quality products from reaching US consumers.”

The same plant meets drug safety standards of Europe, but ‘unsafe’ for America!

Quite contrary to the above stern statement of US-FDA, according to the above report from Reuters, European drug regulators commented as follows:

“The inspection team concluded that there was no evidence that any medicines on the EU market that have an active pharmaceutical ingredient manufactured in Toansa were of unacceptable quality or presented a risk to the health of patients taking them.” 

The further added, “This conclusion was supported by tests of samples of these medicines, all of which met the correct quality specifications.”

Regulatory audit standards were the same for both EU and US regulators:

It is also interesting to note from the report that according to a statement from the US-FDA:

“EMA and FDA inspected the Toansa facility using similar quality standards and underlying principles of current good manufacturing practices.”

Was the decision of US-FDA ‘import ban’ subjective?

This critical question arises because of another US-FDA statement that states as follows:

“While inspections were similar, the two regulatory authorities applied their own, differing, regulatory and legal standards to address the violations.”

Subjectivity in decision-making could encourage “Conspiracy Theory”:

Generic drugs currently contribute over 80 percent of prescriptions written in the US. Around 40 percent of prescriptions and Over The Counter (OTC) drugs that are now sold in the United States come from India. Almost all of these are cheaper generic versions of patent expired drugs. Total annual drug export of India, currently at around US$ 15 billion, is more than the domestic turnover of the pharma industry. Hence, India’s commercial stake in this area is indeed mind-boggling.

In a situation like this, the apprehension of subjectivity in the decision making process of US-FDA related to ‘import bans’, if linked with, say for example, even the missed opportunities for ‘first to launch’ generic versions of several patent-expired blockbuster drugs in the United States by Ranbaxy, could lead to much undesirable ‘Conspiracy Theory’, further souring the relationship between India and America.

As I mentioned in one of my earlier blog posts titled “Loss of Ranbaxy Gain of Big Pharma…And Intriguing Coincidences”, when the emerging dots associated with the missed opportunities for ‘first to launch’ generic versions of drugs like, Lipitor (Pfizer), Diovan (Novartis) and Nexium (AstraZeneca) are connected, an uncomfortable pattern could emerge favoring Big Pharma and obviously adversely affecting Indian companies like Ranbaxy.

The First Dot: Uncertainty over Lipitor generic launch:

Like many other large Indian players, ‘first to launch’ strategy with the new generic drugs has been the key focus of Ranbaxy since long, much before its serious trouble with the US-FDA begun in 2008. ‘Import Bans’ on two of its manufacturing facilities by the US regulator in that year created huge uncertainty in its launch of a generic version of Pfizer’s anti-lipid blockbuster drug Lipitor in 2011. On time launch of a generic version of Lipitor was estimated to have generated a turnover of around US$ 600 million for Ranbaxy in the first six months and commensurate loss to Pfizer for the generic entry.

Despite its neck deep trouble with the US-FDA at that time, Ranbaxy ultimately did somehow manage to launch generic Lipitor, after partnering with Teva Pharmaceutical of Israel.

The Second Dot: Indefinite delay in Diovan generic launch:

Lipitor story was just the beginning of Ranbaxy’s trouble of not being able to translate its ‘first to launch’ advantage of patent-expired blockbuster drugs into commercial success, thus allowing the Big Pharma constituents to enjoy market monopoly with their respective blockbuster drugs even after patent expiry.

Despite Ranbaxy holding the exclusive rights to market the first generic valsartan (Diovan of Novartis and Actos of Takeda) for 180 days, much to its dismay, even after valsartan patent expiry in September 2012, a generic version of the blockbuster antihypertensive is yet to see the light of the day. However, Mylan Inc. has, now launched a generic combination formulation of valsartan with hydrochlorothiazide.

US-FDA drug ‘Import Ban’ from the concerned manufacturing facility of Ranbaxy gave rise to this hurdle favoring the Big Pharma, as discussed above.

As a result, Novartis in July 2013 reportedly raised its guidance announcing that the company now expects full-year sales to grow at a low single-digit rate, where it had earlier predicted net sales to turn up flat. It also guided for core earnings to decline in the low single digits, revising guidance for a mid-single-digit drop.

The Third Dot: Delay in Nexium generic launch:

Ranbaxy had earlier created for itself yet another opportunity to become the first to launch a generic version of the blockbuster anti-peptic ulcerant drug of AstraZeneca – Nexium in the United States, as the drug went off patent on May 27, 2014. However, due to recent US-FDA import ban from its Toansa plant, this opportunity too seems to be fading away for Ranbaxy.

Delay in the launch of generic Nexium, which incidentally is the second-biggest seller of AstraZeneca, would make a big impact on the predator-chased company’s profit.

With the global sales of Nexium at US$ 3.87 billion and US sales at US$ 2.12 billion in 2013, retaining its monopoly status in the all-important US market beyond the end of May would not only limit a forecast decline in AstraZeneca’s 2014 earnings, but would also protect bonuses for top management of the British pharma giant, as the above report says.

Conclusion:

Let me hasten to add yet again, while highlighting the stark differences of interpretations on drug quality standards of the same plant between the European and American regulators and connecting the dots of significant missed opportunities of the Indian drug manufacturers, I do not intend to postulate any ‘Machiavellian Hypothesis’.

I just wanted to establish that both alleged ‘subjective’ decision making process of the US-FDA and coincidences of a series of missed opportunities encountered by the Indian drug manufacturers related to first to launch generics in America are now realities, which if remain unaddressed could germinate into a ‘Conspiracy Theory’, at least in some corners. This could further sour existing Indo-US relationship.

While, I am confident that the new government of India with its, so far, well demonstrated ‘Can Do’ spirit would take these critical issues up in the ensuing bilateral ministerial level meetings, an immediate and in-depth study should also be initiated with valuable inputs from the independent experts to ferret out the real reasons behind these facts, including:

  • Why are the cGMP related issues in India repeatedly arising mainly with the US-FDA?
  • Are  the requirements of the US-FDA though too onerous for the Indian drug manufacturers, yet reasonable as per global norms?
  • If so, how come the drugs manufactured in the same Indian plant though declared unsafe by the US-FDA, considered safe by the European regulators?

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.

 

 

 

Have the successive ‘Drug Policies’ of India delivered? If not, why not?

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January 11, 2011 edition of ‘The Lancet’ in its article titled, “Financing health care for all: challenges and opportunities” commented as follows:
“India’s health financing system is a cause of and an exacerbating factor in the challenges of health inequity, inadequate availability and reach, unequal access, and poor-quality and costly health-care services. The Government of India has made a commitment to increase public spending on health from less than 1% to 3% of the gross domestic product during the next few years…. Enhanced public spending can be used to introduce universal medical insurance that can help to substantially reduce the burden of private out-of-pocket expenditures on health.”
The “Drug Policy “of India:
The new ‘Drug Policy’ of India, which is long overdue, should address all these key issues, as articulated by ‘The Lancet’. Unfortunately, outdated ‘1995 Drug Policy’ is still operational, since last fifteen years. The reason for inordinate delay in putting a new, robust and more reform oriented ‘Drug Policy ’in place is still not known to many, as it is probably languishing in the prison of indecision of the bureaucracy of the country.
The ‘Drug Policy 1986’ clearly enunciated the basic policy objectives relating to drugs and pharmaceuticals in India. After around 25 years, should not the government, at the very least, ponder to assess whether the successive drug policies have delivered to the nation the desirable outcome or not?
In my view, the objectives of the new ‘Drug Policy’ should help accelerating the all-round inclusive growth of the Indian pharmaceutical industry to make it a force to reckon with in the global pharmaceutical space. The drug policies are surely not formulated just to implement rigorous price control measures for drugs. The policy should also formulate other key measurable initiatives, assigning specific accountabilities, to contribute significantly towards achieving the healthcare objectives of the nation. The policy should also encourage working closely and in tandem of all the related ministries of the government.
Financial protection against medical expenses for all is very important:
One of the very major issues in the healthcare space of the country is high out of pocket expenses by the majority of our population. “Financial protection against medical expenditures is far from universal with only 10% of the population having medical insurance” in India. (Source: Lancet Jan 11, 2011).
A comparison of private (out of pocket) health expenditure: (Source: Lancet)
1. Pakistan: 82.5% 2. India: 78% 3. China: 61% 4. Sri Lanka: 53% 5. Thailand: 31% 6. Bhutan: 29% 7. Maldives: 14%
The key issue remains unresolved:
The above edition of ‘The Lancet’ has highlighted that outpatient (non-hospitalization) expenses in India is around 74% of the total health expenses in India and the drugs account for 72% of this total outpatient expenditure. The study has also highlighted that 47% and 31% hospitalization in rural and urban areas respectively are financed by loans and sell of assets.
Drug Prices in India:
The cost of medicines, especially the essential medicines in India, is one of the lowest in the world, even more economical than our neighboring countries like, Bangladesh, Sri Lanka and Pakistan. Moreover, as per DIPP data the inflation index of medicine in 2009 was much lower at 112.32 against the same for all commodities in the same year at 127.47. National Pharmaceutical Pricing Authority (NPPA) also indicated that there was almost no rise (+0.5%) of drug prices in 2010 over the previous year because of effective ‘Drug Price Monitoring mechanism’ by the regulator and fierce market competition.
Around 38% – 40% of Indian population can’t afford to spend on medicines:
While framing the ‘Drug Policy’, the government should also keep in mind that a population of around 38 to 40% of India, still lives below the poverty line and will not be able to afford any expenditure towards medicines. Adding more drugs in the list of essential medicines and even bringing them all under stringent price control will not help the country to resolve this important issue, in the prevailing situation.
The key focus area of successive ‘Drug Policies’ of India has been just ‘price’:
The reform initiatives enunciated by the government in the successive drug policies have been considered by the pharmaceutical industry, in general, as far from satisfactory. In the era of globalization, where market forces play a dominant role to control prices, including the essential commodities, the rigors of stringent price control on pharmaceuticals need to be addressed urgently. This was re-enforced even in the ‘National Economic Survey Report of 2009′.
Will continuation of the same focus be able to resolve the issue?
I do not think so. Continuation of the focus on price since last four decades has certainly enabled the government to ensure that drugs prices in India are cheapest in the world. However and very unfortunately the ‘Drug Policies’ with focus on price alone have not been able to ensure even today that 47% and 31% of hospitalization in rural and urban areas, respectively, are financed by robust healthcare financing systems and not by private loans and selling of assets by individuals.
Expectations from the new ‘Drug Policy’:
Adequate and immediate policy measures to respond to the needs of a robust healthcare financing model for all strata of the society are absolutely critical to address this pressing issue. Effective penetration of health insurance, will, therefore, be one of the key growth drivers not only for the Indian pharmaceutical industry, but also to ensure its inclusive growth, as desired by many.
Conclusion:
Unfortunately, the ‘Drug Policies’ of India have not been able to keep pace with the globalization process of the country as compared to even those industries, which are dealing with the essential commodities, like pharmaceuticals. The amended Indian Patents Act came into force in the country in January 2005. The drug policy of India, for various reasons, has not been able to articulate, as yet, specific key measures to encourage innovation, giving a new thrust to the pharmaceutical R&D space of the country, as much as it should have been.
The ‘New Drug Policy’ should have clear and transparent provisions of stringent drugs ‘price monitoring’ mechanism by the NPPA. The policy should also include an equally transparent system to ensure that errant pharmaceutical players, if any, who will be caught with profiteering motives, under any garb, at the cost of precious lives of the ailing patients, are brought to justice with exemplary punishments, as will be defined by law.

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.

‘Swine Flu’ – why create so much of scare to disturb public life?

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Why has so much of scare been created on ‘Swine Flu’ in India? Who are responsible for creating and spreading such panic?Any attempted answers to these question perhaps will remain baffling to many of us when we read that out of the total population of India, 1159 cases of ‘Swine Flu’ have been reported with 17 cases of death, as on August 12, 2009.Deaths due to other communicable diseases, including seasonal Flu, are far more than ‘Swine Flu’:

While looking at the above simple statistics, I wonder why we all fail to create a fraction of such awareness campaign for other almost equally infectious diseases in India, like malaria, tuberculosis, measles, and diarrhoea.

It is important to note, WHO reports that the seasonal influenza causes about 250,000 deaths per year. Deaths due to some other communicable diseases are also very significant and are as follows:

1. Tuberculosis: 365,000

2. Measles, Diphtheria: 287,000

A mad rush for H1N1 screening and test:

Due to such scare and panic, only in Mumbai 3,768 persons showed up for H1N1 screening in various Government hospitals just in one day on August 11, 2009 between 9 am and 5 pm. After screening all these people, only 448 individuals were identified for H1N1 test and only 14 of them were quarantined.

Awareness and preventive guidelines are necessary – without creating a mass hysteria:

Adequate awareness and preventive guidelines are absolutely necessary for any such disease without creating panic. Has H1N1 infection been used as a competitive tool, just as politicians very often do, to achieve relative competitive prowess by some? Highlighting each death due to H1N1 infection as administrative inefficiency and by creating a public scare in that process, no meaningful public health purpose can possibly be served, excepting perhaps attracting the eyeballs.

‘Swine Flu’ – reported to be a very low fatality disease:

2009 ‘Swine Flu’ pandemic is indeed a global outbreak of a new type of virus identified in April 2009 as H1N1. This strain of Flu virus is believed to be a mutation of four types of Flu viruses, one is usually endemic in human, the second one is endemic in birds and the other two are endemic in pigs or swine. This virus like many other infectious diseases, is usually transmitted from human to human.

The incidence worldwide:

Worldwide, out of over 1,62,380 H1N1 positive cases in 168 countries, 1,154 deaths have taken place as of August 4, 2009. Against this number 250,000 deaths per year take place due to seasonal influenza, as stated above . This vindicates that the fatality rate of this disease is indeed quite low, as of now. This percentage may even be lower, if those deaths are excluded, which were due to other conditions and complications not directly related to H1N1 infection.

All countries by and large, are affected by the ‘Swine Flu’ pandemic. WHO’s America’s region, where the outbreak was first detected, reports highest number of deaths with 1,008, followed by 65 deaths by its South-East Asia region, 41 deaths in Europe and 39 in Western Pacific region.

‘Swine Flu’ – reported to be a self limiting disease:

It has been reported that ‘Swine Flu’ is mostly a self-limiting disease. Clinical studies have confirmed that drugs like ‘Tamiflu’ reduce the duration of illness by a couple of days. The symptoms of the disease are moderate. Complete recovery from the disease has also been reported to be common with no future complications.

Panic related to H1N1 is unnecessary and avoidable:

Unfortunately ‘over-awareness’ and over communication of ‘possible fatality’ of the disease have lead to an unnecessary panic in India, especially, around the disease affected regions. Due to such panic people are running around with any slight ‘flu-like’ symptoms, crowding the H1N1 test centres and hospitals where the chances of getting infection by a non-infected person from others infected with H1N1 virus will be many times more.

Strain on scarce medical resources:

This mad rush, on the other hand, is putting unnecessary strain on the scarce medical resources of those towns and cities where the incidence of H1N1 infection is relatively more . Schools, shopping malls are being closed down and many important programs are being postponed. Migration of people from infected to non-infected places is further jeopardising the situation.

Conclusion:

Both tangible and intangible losses created out of ‘Swine Flu’ scare are bound to be quite significant. Who will take the responsibility of creating this nightmare?

We have our usual ‘punching bag’, the Government of course, to keep on bashing for any such issues totally forgetting our own responsibilities, individually or collectively. There is a silver lining though. A sense of responsibility, at last, appears to be slowly dawning on to those who really matter. Those who had ignited this fire of fear are now trying to douse it by themselves and in the best way as they possibly can. Obviously after much damage has been done. I take it as ‘better late than never’. But the moot question will still haunt many. Have we learnt anything out of this artificial crisis created through a real panic of H1N1 infection? Was it necessary? Has it served any meaningful purpose to the common man in general?

By Tapan 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.

Why is China surpassing India almost in all the verticals of Pharmaceutical industry?

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To make India a major hub for Pharmaceutical outsourcing of all types, the country has all the required ingredients. India has indeed the potential to be a contender for global supremacy, in these fast growing sectors. However, despite all these, China is racing ahead to effectively avail these global opportunities and in that process fast distancing itself from India, widening the competitive performance gap between the two countries.Why is it happening? In this article, I would like to focus on some of these areas to assess the progress made so far, in a comparative yardstick, by these two countries and the key factors responsible for such growing disparity.China is ahead of India in country ranking both in value and growth terms:

In global ranking, China is currently the seventh largest pharmaceutical market and is expected to be the fifth largest market by 2010 and the third largest by 2020. The Chinese pharmaceuticals market is expected to grow by around 15% per annum at least in the next five years.

China is also ahead of India in healthcare coverage of its population:

In China, out of a population of 1.3 billion, 250 million are covered by insurance, another 250 million are partially covered by insurance and balance 800 million are not covered by any insurance. Against these statistics of China, in India total number of population who have some sort of healthcare financing coverage will be around 200 million and penetration of health insurance will be just around 3.5% of the population. India is fast losing grounds to China mainly due to better response to healthcare infrastructure and regulatory challenges by China.

Strong commitment of the Chinese Government in globalization process:

A very high level of commitment of the Chinese Government to make China a regional hub of pharmaceutical R&D and contract research and manufacturing (CRAM) activities within next seven to ten years is paying rich dividends.

Department of Pharmaceuticals (DoP) of the Government of India (GoI)recently expressed its intention to make India a R&D hub in not too distant future. This cannot be achieved just by good intent of investments of couple of million U.S$ through public Private Partnership (PPP), as announced by the DoP recently through the media . A strong commitment of the GoI to hasten regulatory reform processes with visble action, will be the deciding success factor. IPR regime in the pharmaceutical industry has been put in place, but in half measure. While product patent is in place, regulatory data protection (RDP) both against disclosure and unfair commercial use is yet to see the light of the day.

Regulatory data protection and better infrastructural facilities make China a better destination for Clinical Trials:

In China, the local law provides for 6 years regulatory data protection (RDP). Drug Registration Regulation (DRR) September 2007 of China is based on common technical data standards and allows only use of published data during protection period. In preclinical testing and animal experimentation, China is far ahead of India, because of regulatory constraints in our country. The report from ‘Biospectrum, Asia edition, Resource Guide 2009’, the number of Clinical trials being conducted in China was 961 against 834 in India. As a result, towards clinical trials China is attracting more foreign direct investments (FDI) than India.

‘Country Attractiveness Index’ for clinical trials:

‘A.T. Kearney’ developed a ‘Country Attractiveness Index’ (CAI) for clinical trials for pharmaceutical industry executives to make more informed decision regarding offshore clinical trials. As per this study, the CAI of China is 6.10 against 5.58 of India.

China is ahead of India in pharmaceutical patent filing:

In patent filing also China seems to ahead of India. Based on WIPO PCT applications, it has been reported that 5.5% of all global pharmaceutical patent applications named one inventor or more located in India as against 8.4% located in China. This will give an Indication how China is making rapid strides in R&D areas.

China will replace India as country with largest pharmaceutical exports, by 2010:

Both India and China used to be the preferred pharmaceutical outsourcing destinations across the globe. Though pharmaceuticals exports of India are currently ahead of China, PriceWaterhouseCoopers (PWC) reports that China may reverse this trend by 2010, establishing itself as the largest country in the world for Pharmaceutical exports. In API exports, China already overtook India in 2007. The report titled, “The Changing dynamics of pharmaceutical outsourcing in Asia” indicates that in 2007 against API exports of U.S$ 1.7 billion of India, China clocked a figure of US$ 5.6 billion. In 2010, China is expected to widen this gap further with API exports of U.S$ 9.9 billion against India’s U.S$ 2.8 billion.

Brain drain from India to China:

Korn/Ferry International has reported recently that more and more Indian talent is being pulled to China to fill key roles, especially in the API sector, signalling ‘brain drain’ from India to China.

Where India is regarded as a preferred destination:

However, India is globally considered as a more mature venue for chemistry related drug-discovery activities than China. Probably, because of this reason companies like, Ranbaxy, Aurigene, Advinus, Piramals and Jubilant Organosys could enter into long-term collaborative arrangements with Multinational Companies (MNC) to discover and develop New Chemical Entities (NCEs).

As I said earlier and as reported by Korn/Ferry that China’s infrastructure in the pharmaceutical space is better than India, primarily due to firm commitment of the Chinese government to accelerate reform measures to fetch maximum benefits of globalization process in the country.

Government of India seems to have fallen short of this commitment and is embracing more protectionists policies, which have been proved counterproductive almost all over the world to bring forth rapid progress to the nation and make the industries globally competitive.

Just a wishful thinking sans prudent regulatory policy reforms processes will helplessly make us see the gap between the Chinese and Indian pharmaceutical industry, fast widening.

By Tapan 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.

Growing menace of counterfeit drugs in India: why is the domestic pharmaceutical industry still so apprehensive with the new Amendments of the ACT?

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The growing menace of Counterfeit drugs has remained a serious threat to the healthcare space of India.
Do we have any credible data to assess the magnitude of this menace in India?

No we do not have, as yet. At this stage, the magnitude of the problem is anybody’s guess. Earlier a study sponsored by the World Health Organization (WHO) and conducted by SEARPharm reported that only 0.3% drugs were spurious and 3% of drugs were counterfeits.

Government of India has initiated the largest study in the world to quantify the problem:

To scientifically assess the magnitude of the problem in terms of real size of counterfeit drugs market in India , the Drugs Controller General of India (DCGI) India’s, for the first time ever, has initiated one of the largest studies in the world, as reported by the Times of India May 14, 2008.

The study has already identified 61 popular drug brands from nine therapeutic categories for testing 24000 samples. These include drugs prescribed for tuberculosis, malaria, allergic disorders, diabetes cardiovascular conditions, vitamins etc. This study is expected to cost 50 million rupees or about U.S$1.0 million and is expected to be published, soon.

Making provisions for stricter penalties through amendment of the Drugs and Cosmetics Act, 1940:

To bring into effect stricter penalties for those involved in counterfeit drugs, the process of amendment of the Drugs and Cosmetics Act, 1940 was proposed by the Ministry of Health in October, 2007. These amendments are expected to make the drug-related offences, cognisable and non-bailable.

The latest amendment to the Drugs and Cosmetics Act, 1940 became a law in 2008. The punishment for selling or distributing spurious drugs, which are likely to cause death and grievous hurt to the patients, is now imprisonment for a term not less than 10 years and fine not less than Rs 10 lakh or three times the value of drugs confiscated, whichever is more.

The Minister of Health of India announced in November 2008, that with this amendment the Government of India will “go all out to do away with spurious drugs.”

India working closely with WHO Anti-counterfeiting Taskforce:

India being a part of ‘International Medical Products Anti-Counterfeiting Taskforce’ (IMPACT), established under WHO in 2006, decided to work together to combat the growing menace of counterfeit medicines.

The Drugs Controller General of India (DCGI) was reported to have several discussions with the convenor of the IMPACT to effectively address the issue of such serious threats to the patients at large. Many people believe that China and India are the main source of counterfeit drugs in the world.

Apprehensions of the Indian Pharmaceutical Industry with new Amendments in the Law:

Indian Pharmaceutical Industry although welcomed the stricter punitive provisions in the law, expressed its apprehensions due to lack of clear demarcation between the definitions of spurious drugs and those which can lose their original potency because of improper transportation and storage.

If the law-enforcing authorities pick up such medicines from retail outlets, those can easily get categorised as spurious medicines under Section 17A and 17B of the Drugs and Cosmetics Act, 1940. Consequently the concerned manufacturers could be put behind bars with, presumably, no fault at their end.

While stringent punishment is essential for those involved in such heinous crime, the Government should take enough measures to ensure that genuine drug manufacturers are not harassed by the law enforcing authorities, as the courts will have no judicial discretion to award less than minimum punishment, as prescribed under this Act.

Need for clear guidelines for implementation of the amended ACT:

To allay the major apprehension of the industry regarding possible misuse of some provisions of the Act, the Ministry of Health is expected to work out and quickly announce clear guidelines for implementation of the act by the law enforcement agencies in different parts of India.

Will this amendment help to win the fight against counterfeit drugs?

Only time will be able to give that answer. However, by amending the Act, the Government of India has demonstrated its resolve to address the threat of counterfeit drugs with iron hand. Through enunciation of above guidelines, all concerned are expected to be taken on board to effectively curb, if not totally eliminate this growing menace, for the sake of humanity.

By Tapan 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.