Transaction Price Vs Long Term Outcome: What does the data say about affordability?

Posted by on Apr 26, 2017 in Blog | 1 comment

Now that we understand what “generic” means in the Indian context, lets look at whether we have any historical evidence of these “generic” medicines actually saving us money. The only studies that I know of are from public sector entities, the Central Government Health Scheme, the Indian Army and the Indian Railways. I have written extensively about these reports in my past blogs.

Anecdotally, yes, the price we pay at the pharmacist for a generic prescription is often lower than its comparable promoted brand. The reason is simple. There are costs to promote a product. You need people who go to clinics to extoll the virtues of your product, television and paper advertisements, goodies to the practitioners to induce them to write a prescription and so on. And those costs get added to the product price which we end up paying at the counter. So in principle, yes, for that transaction, as a consumer, I pay less than what I would if I chose a “promoted” branded drug.

Now lets look at what these public sector organizations, which supposedly were tasked to procure “generic” drugs for the benefit of their membership found.

For samples which were tested from the Armed Forces Medical Stores Depot (AMFS), the CAG report notes that the rate of rejection for locally procured medicine, due to samples failing quality tests, increased from 15% to 31% during 2006-07 to 2010-11. The average rate of rejection during the three year period of 2008-09 to 2010-11 was therefore 24% approximately. This means that one in every four drugs dispensed by these organizations is not of standard quality.

In its report no. 28 of 2014 on the Railways Hospitals, the CAG noted that substandard drugs worth Rs. 21.45 lakh were supplied to 20 hospitals over 8 different zones of the railways. As noted by PAC Committee in its report between 2009-2012, CGHS, Bombay had reported Rs. 28.45 lakhs worth of drugs as sub-standard. Of these medicines, stock worth Rs. 15.66 lakhs had already been issued to patients.

And then there is the experiment we call Jan Aushadi stores (JAS). Factly reports that one half of these stores have no stock to sell. Other than Rajasthan, this has been an abject failure as the graphic on the Factly website shows. A recent study by the Center for Health Policy at the Tata Institutes of Social Sciences said “From the policy perspective, it raises serious questions regarding the pricing of medicines in JAS and the goal to be achieved. With information asymmetry and supplier induced demand feature in the healthcare market, the OOP expenditure due to medicines is unlikely to decline in India with the existing JAS.”

I will not go into the reasons why Non-Standard Quality medicines are harmful. My past blogs explain this in great detail. Suffice to say that focussing just on the price that we pay at the counter is not very productive. There are larger, systemic issues that need to be fixed first.

When was the last time you went to a doctor and asked him to write a prescription for the cheapest drug? I have asked this question of many who I know and I got no positive answers. Instead, I got weird looks! Although my unscientific survey did not include someone who makes 500 rupees a day, I venture to guess that even he would ask the doctor to give him the “best” medicine, not the cheapest.

The best anecdote I read was from a critical-care physician in Mumbai. The most expensive drug she said, and I whole heartedly agree is the one that does not work. And NSQ drugs certainly do not work.

What does this tell us?

It doesnt matter how inexpensive a particular transaction is, without a view on the long term outcome, discussing affordability is moot. We just simply do not have the data to make well-reasoned conclusions that mandating “generic” prescriptions actually helps lower the cost of care.  In such a scenario, why do we spend so much time debating an issue which clearly is not properly defined ? This is a pointless discussion. Yes, it will rile up people on the television and create drama, but will it help us achieve the objective we have set for ourselves?

The only source of scientific evidence of what cheap, poor quality medicines do to public health is in the treatment of malaria, a disease that is endemic to our country as well. For a long time, scholars have studied the effect of substandard, counterfeit drugs that are so prevalent in the supply chain that treats this disease. The evidence unequivocal. Poor quality drugs cause (a) economic sabotage; (b) therapeutic failure; (c) increased risk of the emergence and spread of resistant strains of Plasmodium falciparum and Plasmodium vivax; (d) an undermining of trust/confidence in healthcare stakeholders/systems; and, (e) serious side effects or death. I am sure you agree that the cumulative cost of handling these outcomes is much larger to us as a country than the cost of the transaction at the pharmacy counter.

Good governance means not making policy based on anecdotes and emotive issues; rather, using actual data to formulate policy and define criteria to measure its effectiveness once implemented. I hope our Niti Ayog is listening.

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The real answer to affordability

Posted by on Apr 25, 2017 in Blog | 0 comments

Over the last two weeks, there has been a spirited debate about how to make medicines affordable to the citizens of India. Driven by the Prime Minister’s call to make less expensive medicines available to the people of the country, there have been several news-reports and well meaning discussions on this topic in the print media and on television. While these discussions seem to present every stakeholder’s point of view, no one seems to be interested in understanding how to best go about achieving this well-intentioned objective.

I wanted to take a step back and ask a few questions to all who profess to have an opinion on this issue.

  1. What data do we have to inform us that switching to a generic version of the drug saves us money?
  2. Do we want to discount the clinical experience of your doctor and impose restrictions on what to prescribe on her?
  3. How confident are we that this mandated “generic version” only prescription actually works as intended?

Lets get the nomenclature right first. The term “generic” as it is used in the Indian context is not the same as we seem to appropriate from the US context. In the US, “generic drugs” are those which are no-longer protected by patents. In our country, “generic” refers to “unbranded” medicines; because our companies produce and market drugs that are no longer under patent as “branded-generics”. Unless we understand this difference, the rest of the conversation doesn’t make much sense.

The next thing for us to understand is why would a manufacturer “promote” something that is no longer protected by a patent. The assumption we make in this case is that if a product is protected by a patent, the patent holder can charge a higher price  because there isnt anyone to compete against that product. Therefore, pharmaceutical manufacturers bred armies of what we call “medical representatives” who eulogized the benefits of such products to healthcare practitioners. In the Indian context, two different manufacturers could in-principle manufacture the same drug (whether it was protected by a patent until we adopted the TRIPPS agreement was immaterial). Therefore, how does one differentiate (meaning push its product to more consumers) if there is no differentiation in the product itself? Here came the magic of marketing. We devised flashy advertisement campaigns, promoted the virtues of “my” product under the guise of “medical-education” and came up with more innovative strategies which perhaps be left alone. This is how “brands” were born. Pharmaceutical companies used novel and very interesting strategies to ensure that their “brand” sold more than the “other brand” despite the fact that the underlying product was supposed to be identical.

There were other strategies like “Fixed Dose Combinations” that were invented to combine two or more drugs into a “cocktail” under the guise of better patient compliance with the dosing regimen. But that is a topic for another time. Lets just stick to the simple stuff for now.

Inspired by our penchant for jugaad, and the fact that the regulatory framework that was supposed to keep an eye on the industry was fast-asleep in the best case and was colluding the industry at worst, enterprising pharmacists (who made money on the margins that they retained buying from the wholesaler stockist and selling it to gullible patients) developed their own models for how to be profitable. They “pushed” the product that gave them the highest margin on sale. Knowing that two or more of the chemical salts were “supposed” to be similar, what was the harm in “substituting” the more expensive version to the patient? After all, they were running a business, not a charity. They negotiated hard with each brand on their margins and whoever offered them the most was the product of choice. Once they got used to this idea, the next concept of “frugal innovation” was to “make-our-own”. The regulatory framework never asked for any proof of therapeutic efficacy for any drug that was over four years old; so they could set up a tablet-punching machine in a garage and stamp out as many of these pills as they wanted. Because they cut corners at every step, meaning, no process checks, no quality control, their profit margins were the highest. This is how our “unbranded” medicine industry was born.

The pharmacists then “pushed” these unbranded drugs, many of them made in garages and had no efficacy and we ended up with an industry with 30,000 pharmaceutical manufacturers. And because the regulator was so incompetent, it seldom checked for quality or therapeutic efficacy of these products. In those rare cases it did, and its inspectors found problems, our legal-justice system essentially killed their efforts by letting these wrongdoers go with a slap on the wrist.

Now that we understand what “generic” drugs are in the Indian context, I would love to hear from you on what your views are on the questions I have posed above. I was so hoping to hear this on the many shows I have watched and written pieces I have read, unfortunately, they seem to regurgitate the same talking points. I am hoping that we can have a more meaningful discussion here.

More in the next blog.

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An open letter to K L Sharma

Posted by on Jan 24, 2017 in Blog | 5 comments

Shri K L Sharma, Joint Secretary (H), Ministry of Health and Family Welfare

Dear Shri Sharma,

If you recall, I met you in May 2015 after the PMO forwarded my letter to them to you for your consideration. During our meeting, you assured me that the government is taking steps to correct the systemic issues that plague the CDSCO and our regulatory process for approving medicines sold to 1.2 billion Indian citizens.

I am not sure if you have read about the recent observations made by a foreign regulator, US FDA upon inspection of a manufacturing facility of a large manufacturer of Active Pharmaceutical Ingredients located in Telangana. The observations made by the foreign inspectors thoroughly document behavior of the employees of this company which is consistent with inspection findings of almost every other large pharmaceutical manufacturer in India. CCTV records prove that the company destroyed and altered manufacturing records just prior to the inspection.

While we wait for the government to overhaul the Drugs and Cosmetics Act as you indicated to me, how do we ensure that the medicines already in the market today comply to the standards of basic quality to our citizens? I am sure you will agree that there isnt a valid reason to destroy records if everything was done by the book as many of these companies claim they do when manufacturing product for our consumption. Where Sir, is the rule of law that holds the people who indulge in such outrageous behaviour accountable to the people of this country? Isn’t destruction of records a criminal felony? If companies are so emboldened to do this for records for products sold in the US, which I am sure you will agree has a much more stringent quality expectation of their drug supply compared to what we accept in India, what do you think they are doing with the records for products they make for our patients? Do they even document what they do to manufacture products for our consumption? Does anyone care?

The CDSCO and its leadership has lost all credibility among its peers. No one takes what it says seriously anymore. Changing its name to Indian Drugs Administration does nothing to change the culture and the level of competence in our regulator. Creating a long checklist consolidating every observation made by a foreign regulator about our manufacturing facilities does not inspire confidence in our ability to understand what quality means and how to enforce standards in our manufacturing facilities. And issuing notifications to prescribers and consumers to follow label information does nothing to address the underlying problem of substandard drugs; as we have seen in the recent case of drug resistant antibiotics.

It is high time Sir, that the government did something to actually effect a meaningful change in the drug supply for the country. I realize passing legislation is not easy, and I do not envy your job. However, holding people accountable also has to be a part of the equation. When will we learn that cutting corners especially with medicine plays with lives of our citizens? Only when you hold people who do this publicly accountable. I just hope that the credibility that we, the people, have in the government to protect our drug supply doesn’t go the way of CDSCO.

Dinesh Thakur

 

 

 

 

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Will we ever learn?

Posted by on Nov 25, 2016 in Blog | 1 comment

There is news today that the US FDA made observations about Sun Pharma’s facility at Mohali that are very similar to what led to the import alert for products manufactured at this facility back in 2013. The Economic Times and Live Mint both report of what inspectors from the US FDA found about data integrity violations at this facility. Upon closer inspection, these observations are no different from what foreign regulators have been finding and documenting in various actions on the veracity of the data that Indian pharmaceutical companies use  to secure market authorization in their respective countries. A cursory search will list many such examples from both manufacturing and clinical facilities in India.

In parallel, it was reported in the Economic Times that the national drug regulator, CDSCO has inspected approximately 200 manufacturing facilities that supply medicines to the Indian market and found that none of them to be compliant with the Indian version of cGMP (Schedule M). It is a different discussion altogether whether Schedule M is consistent with cGMP, but for the sake of today’s discussion, let us assume that it is. By their own admission, 100% of manufacturing facilities that supply life saving medicine to the India patients do not comply with the standard that the country’s regulator expects them to.

In the past, the standard response from the industry association representing pharmaceutical companies was that somehow western interests were out to defame and destroy the Indian pharmaceutical industry. Clearly, the country’s drug regulator finds substance independent of what foreign drug regulators have consistently found when it comes to compliance with standards for manufacturing medicines. I wonder what the next argument from the industry association will now be?

The larger question to ask is why is it that after three years of not being able to export product to the largest and most lucrative market in the world, the country’s largest pharmaceutical company once again finds itself in the same place it did earlier? Were the army of consultants who professed to “train” its employees not effective? Was the hundreds of millions of dollars of investment which was touted to upgrade its facilities to make it compliant with US standards not enough? Why is it that time again, we come back to the same question?

The answer is not hiring external consultants who charge exorbitant fees  or building shiny new manufacturing facilities to impress the regulators. I spoke about this very topic recently at the Rx360 Annual Conference in Washington DC and here is my take on it.

As to the question of what the DCGI will ever do with its own findings about the 200 odd manufacturing facilities it found not to be compliant with its own standards, I am not holding my breath. Unless the regulation changes, and people are held accountable for making and selling substandard medicines, nothing will change. I had documented cases where despite proving guilt, the legal justice system in the country lets such people go with nothing more than a slap on the wrist. If the highest court in the land thought that was an academic issue, what more is there to say?

 

 

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Differences in approach to regulation: why leadership and science matters

Posted by on Jun 28, 2016 in Blog | 3 comments

In my past blogs, I have documented how the CDSCO and the Drugs Consultative Committee (DCC) have taken decisions that adversely affect public health and give the industry a free pass even in cases where there is clear evidence of the industry breaking the law. Leadership and integrity of the national health regulator is an important factor in how it responds to advancing science. When members of the industry intentionally produce and sell substandard drugs in the country, it is the responsibility of the national health regulator to prosecute them to the fullest extent of the law.

A recent example of the difference in approach between the national regulators of India and US was how the US FDA responded to the complexity of drug formulations and the rules governing bioequivalence. A few weeks ago, the US regulator released 38 new and revised guidance documents that address the challenges of how to assess therapeutic equivalency of generic drugs. Each document also contains information on what analytes should be measured, what dissolution test methods should be used and sampling times.

Issues with existing guidelines for conducting bioequivalence studies was first pointed out to the FDA by People’s pharmacy. They provided conclusive patient outcome data to the regulator about generic Wellbutrin which made the US FDA reconsider its guidelines for establishing therapeutic equivalence of generic drugs. The arguments supporting revision of existing guidelines were explained in this peer-reviewed paper. With mounting evidence, the US regulator initiated a process of reevaluating its approach to therapeutic equivalency of generic drugs and the result is a completely new approach. Earlier this year, the US FDA provided product-specific recommendations for 31 different active pharmaceutical ingredients (APIs) linked to new generic drugs and revised recommendations for 11 APIs. Included in the latest release are guidelines for Everolimus (Novartis’ blockbuster cancer and transplant treatment) and Viekria Pak (Abbvie’s Hepatitis C blockbuster). These drugs were approved in 2009 and 2014 respectively and have no generic equivalents in the market today. This shows that the agency is thinking ahead in providing guidance to the industry which may be working on development generic therapeutic equivalents for these drugs after they go off patent.

Compare this action to how the DCC issued guidelines to undermine therapeutic efficacy of generic drugs sold in India by giving the pharmaceutical industry a free pass when it comes to prosecuting manufacturers of substandard drugs. While the CDSCO guidelines for establishing bioequivalence mirror those that were followed by the US FDA until very recently, the DCC in its 47th meeting held in July 2014 proposed that bioequivalence studies for generic drugs be deemed optional for products sold in India under the guise that infrastructure to conduct those studies doesn’t exist in the country. We all know how many CROs exist in the country, so this argument is blatantly false. What is more ridiculous is that in the same breath, the DCC recommended that bioequivalence studies be conducted for the product made for export. This action clearly undermines the law of the land, the Drugs & Cosmetics Act. Actions such as these go the root cause of the dysfunction within the CDSCO and its function; this is a direct influence of the industry lobby exercising its influence over policy making at the expense of national health.

This is the reason why, in addition to a new set of laws governing manufacture and distribution of drugs, India needs a fundamental change in leadership of the national regulator. As the Parliament Standing Committee said, leadership at the CDSCO is beholden more to the industry’s agenda and interests than the public health of the citizens of India. Unless we bring people with unimpeachable integrity to lead this organization, new laws and regulations will have limited effect on its function.

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Revision to the Drugs & Cosmetics Act – Call for public comment

Posted by on Jun 20, 2016 in Blog | 0 comments

On June 6, 2016 the CDSCO published a notice announcing that it was going to revisit the Drugs & Cosmetics Act, 1940 and Rules, 1945 “to match up with the current regulatory requirements related to safety, efficacy and quality of drugs, medical devices and cosmetics”. The Ministry of Health has called for feedback from all interested stakeholders within 15 days i.e., by June 21, 2016. The comments are to be sent to the JDC (ER), HQ, CDSCO, FDA Bhawan, New Delhi at reddywz@gmail.com .

The Economic Times was the first newspaper to report this on June 8, 2016 in a report available over here. Since then Money Control, India Today, Livelaw and other haves reported on the notice. Most of these newspapers reported the call for comment as late as June 13;  it is not clear as to why the CDSCO is rushing the process by allowing merely two weeks for comments. Even this notice has not received wide publicity.

In any case, I was in the process of compiling a report based on all of my research over the last year. The report is available for download over here and runs into 123 pages. The report covers several of the themes already covered on this blog, along with some new issues. It covers the following topics:

Part I – The fragmented federal drug regulatory framework: This section covers the history and legality behind the creation of 36 state regulators in India;

Part II – The weak investigation & enforcement mechanism under the Drugs & Cosmetics Act, 1940: This section covers in details the various flaws with the manner in which the investigation and enforcement mechanism works on the ground. In specific, the focus is on the yawning gap between the letter of the law and its enforcement on the ground;

Part III – The absence of fundamental quality testing and recall norms: In specific, this section covers the lack of mandatory bioequivalence and stability testing norms in India;

Part IV – The 59th & 66th Report of the Parliamentary Standing Committee on Health & Family Welfare on the functioning of the CDSCO: This section covers the two famous reports of the Parliamentary Standing Committee on Health & Family Welfare which indicted the CDSCO for collusion with the pharmaceutical industry. In specific this report contains detailed follow up action for several of the issues that were first raised by the Standing Committee.

Part V – Sub-standard drugs in the public procurement system: This section covers the problem of rampant presence of sub-standard drugs in publicly funded drug systems.

I encourage everybody to download and read the report to understand the magnitude of the problem faced by the Indian drug regulatory framework. Most of the supporting documents such as the RTI replies, are available on this blogsite.

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The need for an overarching law on public procurement of medicine

Posted by on May 23, 2016 in Blog | 1 comment

Over the last several years, the Comptroller & Auditor General (CAG) has pointed out to serious deficiencies in the public procurement of medicine by major institutions like the Ministry of Railways, Ministry of Defence and the Central Government Health Scheme (CGHS), which is administered by the Ministry of Health & Family Welfare. Some of the findings of these various audit reports are highlighted below:

For samples which were tested from the Armed Forces Medical Stores Depot (AMFS), the CAG report notes that the rate of rejection for locally procured medicine, due to samples failing quality tests, increased from 15% to 31% during 2006-07 to 2010-11. The average rate of rejection during the three year period of 2008-09 to 2010-11 was therefore 24% approximately. This means that one in every four drugs dispensed by these organizations is not of standard quality. This is a shockingly high rate of NSQ drugs which are used to treat people who fight for our country.

In its report no. 28 of 2014 on the Railways Hospitals, the CAG noted that substandard drugs worth Rs. 21.45 lakh were supplied to 20 hospitals over 8 different zones of the railways. The actual figure is most likely higher because as also noted in the same CAG report, the railways hospitals were not conducting mandated pre-dispensing testing of consignments i.e., each consignment of these drugs is required to be tested before being issued to patients. Such pre-dispensing testing is a testimony to the lack of faith in the ability of the DCGI and state drug controllers to effectively regulate quality standards. Can you imagine a drug approved and regulated by the US FDA being subject to this kind of procedure?

Even in cases where pre-dispensing quality testing is conducted, it was found that in 8 hospitals, over 4 railways zones, had dispensed these drugs to patients and then received the test reports indicating that the drugs were NSQ. In one case in Kolkata, 93.8% of a batch of drugs were dispensed before the test reports returned from the lab. Imagine what consequences the patients who got these drugs suffered. In most of these cases, CAG noted that information regarding these suppliers of NSQ drugs was not shared on railnet, “an internal portal”, for information to other zones. Independent of the CAG report, we also filed a RTI application with the Ministry of Railways asking for the names of all the pharmaceutical companies blacklisted by the Indian Railways. To our surprise, we learnt that the Indian Railways does not have a single consolidated blacklist of all pharmaceutical companies which have been debarred from supplying to the Railways because of poor quality products that they supply. Instead our RTI application was transferred to each zonal railways office. We found that each zone had its own blacklist thereby giving rise to the probability that a supplier blacklisted by one zone can still supply to other zone. Of all the zones which provided replies, only the Western Railways, NorthWestern Railways, North-East Frontier Railways & Eastern Zone even had a blacklist. Some of the companies on the list were rather big names like Biocon (blacklisted for Rosuvastatin), RPG LifeSciences (blacklisted for Atorvastatin), Sandoz, Alkem, Alembic Pharmaceuticals, Abbot etc. Some manufacturers like Ind-Swift & CMG Biotech Pvt. Ltd. were blacklisted for all of their products, while the others were blacklisted for only specific drugs that they supplied. Most of the other zones like the Southern Railways, Northern Railways, South Central Railways, East Coast Railways all claimed that they had not blacklisted evena single manufacturer. The lack of a consolidated blacklist is likely creating windows of opportunity for the manufacturers of sub-standard drugs to supply to one zone even after being blacklisted by others.

The CAG Report No. 20 of 2007 (Performance Audit) titled ‘Procurement of Medicines and Medical Equipment’ by government hospitals and CGHS pointed out several deficiencies in the procurement process. Essentially, the entire procurement process was punctuated by completely arbitrary behaviour and lack of set processes or guidelines. One of the key deficiencies pointed out with regard to quality control was the failure of hospitals, including AIIMS to carry out mandatory testing on all procurements before issuing. (para 7.1.8) The CAG report spurred a more detailed examination of the CGHS processes by the Public Accounts Committee (PAC) of the Lok Sabha in its 24th Report (2011) and 84th Report (2013). Some changes were made by the MoHFW, but clearly the changes were not enough because as noted by the PAC in its 22nd Report (2015), sub-standard drugs in the CGHS were still a problem. As noted by the Committee in its report between 2009-2012, CGHS, Bombay had reported Rs. 28.45 lakhs worth of drugs as sub-standard. Of these medicines, stock worth Rs. 15.66 lakhs had already been issued to patients. The Committee had noted “Such instances highlight the absence of a robust mechanism for quality assurance, which exposes the patients to the hazards of sub-standard medicines and drugs”.

In the backdrop of the above reports, we attempted to scrutinise the blacklisting policies followed by the above public authorities to penalise the suppliers of sub-standard drugs. Such blacklisting policies are important because very often, blacklisting is the only punishment meted out to suppliers of sub-standard drugs. Prosecutions are very rare in the Indian context as I have documented in my previous blogs.

As of now, each Ministry follows its own procurement and blacklisting guidelines. While individual Ministries may have different needs, it is surprising to see the degree of variability in each of their blacklisting guidelines. Here are some obvious holes in their procedures:

  • The CGHS blacklisting guidelines are contained in the “Procurement and Operational Manual for Medical Store Organisation and Government Medical Store Depots”. The guidelines basically borrow the classification of various defects with sub-standard medicine from certain DCC Guidelines which creates a classification mechanism of Category A, Category B & Category C defects. In the context of the procurement manual, Category A defect in a product results in the supplier being barred for 3 years and if there is a repeat, then the supplier is barred from supplying any products. Category B defects are treated similarly. Such a system of blacklisting is however rather superficial and fails to understand the nature of the pharmaceutical industry. If a particular batch of medicine fails quality control testing at a certified GMP manufacturing facility (as all Indian pharmaceutical facilities are required to be), it would mean that the facility is not GMP compliant because by their very nature, GMPs create a fool proof mechanism to ensure quality. Every batch has to be tested before it is shipped and the manufacturer has to test the samples before shipping out commercial supplies. In many cases in India, manufacturing problems arise due to non-compliance with GMPs and the defects within a particular batch are merely a symptom of a larger problem within the company. This is the reason why we see a string of warning letters from foreign regulators to the who’s-who of the Indian pharmaceutical industry. Therefore, when a public authority detects quality issues with a particular batch of drugs, it should conduct a deeper investigation and determine the reasons for the problem – in some cases it could be purely a case of cheating or fraud by the supplier to make more profits. In such a case, the entire manufacturing facility should be banned, there is no point of banning the supplier only the one product which has failed the quality control test.
  • MoD’s Policy Regarding Quality Assurance of Drugs and Punitive Action: This policy laid down by the Directorate of Quality Assurance (Stores) follows the same logic as the CGHS guidelines although the parameters for classifying defects are entirely different.
  • The Indian Railways has its own Drug Procurement Policy, 2014. Unlike the MoD or the CGHS guidelines, the Railways doesn’t lay down a product specific blacklisting policy. The guidelines states that if there are adverse reports regarding the performance of a firm, the railways officers will inspect the facility and if the firm continues to fail to comply with orders of the Railway to improve quality it will be deregistered. What makes the Railways officials expert at detecting compliance problems at the manufacturer when they have no formal training in conducting such inspections is a question that is never asked. In practice however, from the blacklists provided to us by the Railways, it is quite clear that some zones like the Western Railways are actually following a product wise ban which is contrary to what is stated in the policy.

Apart from an urgent need to completely replace these blacklisting norms, another major reform required to the current process is to create a consolidated blacklist for all publicly funded entities. As noted in the CAG report, even within the Railways there is little sharing of information on NSQ suppliers.

Given the large amounts of money spent on public procurement of drugs, stronger quality controls norms will not only save public funds but also raise the costs for the inefficient firms who aren’t able to maintain quality. More importantly, they will close the loopholes that the drug companies use to exploit the system.

The best way to achieve the above objectives is for Parliament to enact a law dealing with public procurement of medicine. This was one of the prayers that I had sought in my PIL. Unfortunately, the Supreme Court thought that this was an academic issue.

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