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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Enforcement measures under the Drugs & Cosmetics Act, 1940 – Part 13: What’s in the name?

Posted by on May 10, 2016 in Blog | 1 comment

One of the many problems with the pharma regulation debate in India is the tendency to focus more on “spurious drugs” rather than “sub-standard drugs”. Chances are, we hear more about “Spurious Drugs” when both practitioners (doctors) and patients talk about the quality of our drug supply. It is rare that we ever hear of substandard drugs. Why is that?

“Spurious drugs” which are the same as counterfeit drugs are manufactured with the sole intent of financial gain by passing of fakes as a legitimate product. On the other hand, substandard drugs are manufactured by legitimate manufacturers under their own name but without following good manufacturing practices. As a result, these products are either lower in potency compared to what they say on the label, or contain other substances which are harmful to the patients who take them. It is necessary to draw a distinction between these two because spurious drugs are a ‘law & order’ problem while substandard drugs are a regulatory problem. Contrary to the general belief, substandard drugs are a much bigger problem than spurious or counterfeit drugs in India. The figures below provide hard evidence of this trend:

CDSCO Sampling

Source: http://www.indiaspend.com/cover-story/1-in-7-indian-drugs-revealed-as-substandard-97614

There is a rather simple rationale for this trend. Since the intent behind counterfeiting is financial gain, it makes sense for the counterfeiters to go after high priced products. For example, it makes sense to produce a counterfeit Prada or Louis Vuitton handbags because of the brand equity (price) they command in the market. It makes no sense to counterfeit a no-name product, because the financial incentive simply doesn’t exist. In a country like India, where price-controls are the norm in the pharmaceutical industry; and even for those medicines that are not under the purview of government imposed price controls where the price-point is extremely competitive, does it really make sense for anyone to produce a counterfeit drug? The answer is evident in the chart above.

As you can see, we don’t really have a problem with Spurious Drugs; we do indeed have a problem with Substandard Drugs. The data we have collected through the RTI process tells us that while these numbers are severely under-reported, the trend holds. The prevalence of spurious drugs is infinitesimally small compared to the prevalence of substandard drugs. So why is it that the public debate in India focuses more on spurious drugs?

Our research indicates several reasons for this. One of the likely reasons for this confusion is that there is the generally poor level of awareness about drug regulation in India. There is little understanding about the difference between what is a spurious drug and what is substandard. If we expect grassroot level awareness about the problem with our drug supply, lets first make sure we get the nomenclature right. A less likely, but equally culpable reason is the confusing terminology intentionally used in the Drugs & Cosmetics Act, 1940 to deal with various categories of defective drugs. This is an issue which requires a more detailed explanation.

The various definitions in the Drugs & Cosmetics Act

The law currently contains four different categories of “offences” with respect to quality of a drug or its packaging: “misbranded drugs”, “spurious drugs”, “adulterated drugs” and drugs which fail to comply with “standards of quality” laid down in the Second Schedule to the Drugs & Cosmetics Act, 1940.

Broadly speaking, “misbranded” covers drugs which aren’t labelled as per the law or if the drug makes a false claim for any of its ingredients or if a drug is coloured or powdered to conceal damage and misrepresent its therapeutic value. “Spurious drugs” covers the offence of misrepresenting the manufacturer of the drug or misrepresenting the active ingredient of the drug itself. “Adulterated drugs” includes the addition of any substance that is filthy or putrid or reduces the quality or strength of the drug or if it is prepared and packed in insanitary conditions. Interestingly, “Sub-standard” is not defined in the Act; instead Section 18(a)(1) merely states that the manufacture of drugs which are not of standard quality is prohibited. So much for downplaying the real problem with our drug supply. Mind you, all of the above definitions have been simplified for the sake of this blog post since the actual definitions are a lot more complicated, confusing and overlapping. Various components of the definitions of “misbranded” and “adulterated”, are actually covered by the definition of “not of standard quality”. The graphic below depicts how poorly these categories are defined.

Definitions

Source: http://icrier.org/pdf/Working_Paper_310.pdf

As if the confusion created by these arbitrary classification is not enough, there are the DCC guidelines discussed in an earlier post, which create artificial categories like “grossly sub-standard drugs” and drugs with “minor defects”. Does it come as a surprise to anyone that the most common parlance for public discussion therefore gravitates toward the terminology most “marketed” by the industry, namely Spurious drugs?

The multiple definitions of, what is essentially bad medicine, directly affects the legal and public debate because it creates confusion in the minds of policy-makers and journalists as to which type of offence covers what kind of defect in the drug. This is perhaps one of the reasons we see people in public office and media use spurious, adulterated, misbranded and not of standard quality in an interchangeable fashion.

The American approach to defining bad medicine

On the other hand, the United States for example has two simple categories: one is adulterated drugs and the other is misbranded drugs. Although the definitions are detailed, the simple categorisation helps to simplify the public debate since the media has to deal with only two simple categories.

An additional advantage of the American approach over the Indian approach is that it focuses even on manufacturing processes unlike the Indian definitions which focus only on the end product. Under American law, there is a presumption that if a drug fails to comply with good manufacturing practices (cGMP), the end product is adulterated. I reproduce the relevant portion of the definition:  “if it is a drug and the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice to assure that such drug meets the requirements of this chapter as to safety and has the identity and strength, and meets the quality and purity characteristics, which it purports or is represented to possess”

There is no such presumption in Indian law. Our approach to quality is focussed on evaluating the marketed drug against a set of standards established by the Indian Pharmacopoeia. No wonder that while the American and European drug inspectors repeatedly find and penalize questionable practices among the Indian manufacturers, the CDSCO’s track record is all but making empty threats.

This is one of the reasons why one of my PILs sought to clean the current slate so that we could begin by creating a modern framework for regulating drugs in India. Unfortunately, the Supreme Court thought this was an academic issue. The fact that such confusion affects law enforcement and public health of over a billion people who live in India is somehow lost in translation.

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