One of the most startling discoveries of our research into the manner of enforcement of drug regulatory laws in India is the fact that a majority of NSQ cases in India are not even prosecuted. Sadly, this lack of prosecution is not due to lethargy or incompetence but a conscious decision taken by the Drugs Consultative Committee (DCC) to dilute the quality standards that are prescribed in the Drugs & Cosmetics Act, 1940. These “Guidelines for taking action on samples of drugs declared spurious or not of standard quality in the light of enhanced penalties under the Drugs & Cosmetics (Amendment) Act, 2008” were decided in the 40th meeting of the DCC. The guidelines were meant to provide a framework for Drug Inspectors to enforce the Drugs & Cosmetics Act but in reality the final version of the guidelines provide a roadmap for circumventing and diluting the very mandatory standards prescribed by the Drugs & Cosmetics Act.

As per Section 16 of the Drugs & Cosmetics Act, 1940, standards of quality required to be followed in India for medicines are laid down in Schedule II to the Act. This schedule recognizes the standards described in the Pharmacopeia of various countries including the Indian Pharmacopeia. When samples are drawn from the market, they are tested as per the standards prescribed in the Pharmacopeia adopted by the manufacturer. These standards can be viewed on the labeling of the drug. For example, most Indian drugs will bear the phrase “IP” to demonstrate that they are following the standards laid down in the Indian Pharmacopeia. The Indian Pharmacopeia provides a reference standard, which is established and maintained by the Indian Pharmacopeia Commission (IPC) – which functions directly under the Ministry of Health & Family Welfare (MOHFW). When samples of drugs are drawn from the market by drug inspectors and sent to government laboratories for analysis, they are tested as per the protocols established in the IP. Each sample is usually tested for content of active ingredient, its dissolution profile, disintegration, visual description and uniformity of weights. Each one of these tests is important to establish whether a drug will have therapeutic value for the indication it is prescribed.

An assay test, aimed at establishing the content of the active ingredient, is important because it tests the quantity of the active ingredient in the tablet against the quantity advertised on the labeling. The IP usually allows for a 10% margin of error; i.e., the assay result can be within 90% to 110% of the quantity advertised on the labeling. If the API is above or below these limits, the drug will likely not have its intended effect and may in some cases – depending on the disease – cause grievous hurt or death to the patient. Similarly if a drug fails a dissolution test or disintegration test, the drug is very likely to not dissolve into the blood stream of the patient according to the prescription parameters and can either have little or absolutely no effect on the medical condition that it is supposed to treat. Again, depending on the medical condition, the failure of such a drug may cause grievous hurt or death to the patient. In either case, once it is established that the drug has failed the standards laid down in the IP, the govt. analyst will declare the drug to be NSQ and as per the Drugs & Cosmetics Act, 1940. The manufacturers of such NSQ drugs have to be prosecuted under Section 18(a)(i) read with Section 27(d) according to the prevailing law. However the reality of drug enforcement in India is very different because of the DCC guidelines.

These Guidelines prescribed by the DCC lay down an entirely different set of parameters. It creates three categories: Category A, Category B & Category C according to the nature of defect and recommends a different strategy of punishment for each category of violations. For example, Category A basically deals with spurious or counterfeit drugs where stringent criminal prosecution is recommended. Category B deals with cases of grossly sub-standard drugs – such drugs are those which have less than 70% of the API compared to what was advertised on labeling, drugs which fail disintegration tests, dissolution tests, parental preparations failing sterility tests, vaccines failing in potency tests, presence of any adulterant which renders the product injurious to health. In all of these cases for Category B, the DCC Guidelines prescribe criminal prosecution only if the drug inspector feels that the defects are due to gross negligence or criminal intent and only if milder punishments like suspension or cancellation of manufacturing licenses are deemed to be inadequate.

This aspect of the guidelines is inherently illegal for two reasons:

The first illegality is that the Guidelines essentially bypass the binding standards laid down in the IP by prescribing its own standards. As per the Act, it is quite clear that once the IP standards are breached, a drug is NSQ and the manufacturer of such drugs has to be prosecuted according to the law. There are no exceptions in the law. It is illegal for the Guidelines to recommend its own threshold for criminal prosecutions and most importantly the guidelines lack any medical rationale for the basis of their recommendations. For instance, a drug which fails a disintegration or dissolution test, is as good as chalk or a spurious drug – similarly when the IP prescribes a lower limit of 90% for assay tests, why should the guidelines further drop the threshold to 70% despite the fact that in the case of some drugs such a difference can actually cause mortalities? All such cases should automatically result in a criminal prosecution under criminal law; instead the guidelines ask the drug inspector to consider prosecutions as second option to the preferred option of suspending or cancelling a manufacturing license. The suspension of licenses which appears to be the preferred remedy of drug inspectors is a red herring because there is no monitoring mechanism to enforce the suspension. Criminal prosecution is the only real punishment in such cases.

The second illegality with the Guidelines is that it requires Drug Inspectors to ascertain the criminal intent or negligence of the manufacturer – however, there is no requirement in the Drugs & Cosmetics Act, to ascertain the mens rea or mental intent of the manufacturer while prosecuting a NSQ case. Once a breach of the law is established in such cases, a criminal prosecution is necessarily mandated under the law. Guidelines which are drafted by statutory authorities like the DCC cannot undermine the letter of law laid down by Parliament. That is the law of the land. It is simply astounding to see the audacity with which these guidelines recommend circumventing the law laid down by Parliament.

It is a different matter altogether why this artificial construct of distinction between counterfeit and sub-standard drugs was intentionally designed by the DCC to create so many categories which lead to this situation. Counterfeiting a product makes sense only where there is a real financial gain. In a country like India, where price controls are the norm, what does a counterfeiter stand to gain in terms of profit? Anecdotal data shows that the preponderance of the problem in India is substandard drugs, not counterfeit as the industry claims. Unfortunately, other than industry funded studies to support their absurd assertions, India does not have independent think-tanks and research bodies which study this issue and can provide unbiased reporting of the data. One can only imagine the role the pharmaceutical lobby played in the DCC creating these illegal guidelines, which are clearly designed to protect the members of the lobby by circumventing the law of the land.

In one of the PILs that I had filed before the Supreme Court, I sought to challenge the constitutionality of these guidelines. Declaring these guidelines to be unconstitutional would have required Drug Inspectors to mandatorily prosecute all cases where drugs failed to meet the standards prescribed by the IP. As things stand now, a vast majority of NSQ cases are not even criminally prosecuted since drug inspectors prefer suspending licenses as recommended by the DCC guidelines despite the fact that such suspensions are a complete eye-wash and there is no way to monitor compliance in such cases. In some states, the period of suspension is a ridiculous 1 day or at most a week. On the other hand a criminal prosecution can result in both imprisonment and fines. Unfortunately, the Supreme Court thought this was an academic issue and was reluctant to hear these issues, which go to the core of the regulatory problem in India.