The , which was recently passed by the Lok Sabha, has provoked a controversy regarding its implications for public health in India. This after the government put out a rather in response to that one of us made on Twitter.
Simply put, the government press release seeks to perpetuate its earlier claim that the bill aims to decriminalise only minor offences. This is simply not true because amendments pertaining to the goes to the core of drug quality.
The act currently prescribes four different categories of offences pertaining to drug quality. These are adulterated drugs, spurious drugs, misbranded drugs and finally “not of standard quality”, or NSQ, drugs. The legal definition for each of these categories is complicated, but a summary of each category along with the punishment prescribed in the act is explained below:
Of the four categories above, the Jan Vishwas Bill converts all offences punishable under section 27(d) into compoundable offences, meaning that the accused can escape jail time upon payment of a fine of Rs 20,000 A for compounding such offences first originated in the which was published by the government for comments last year. It was no surprise when it made its way into the too since the pharmaceutical lobby has hard for decriminalisation of section 27(d) since it is the most frequently invoked provision by drugs inspectors in India.
In its rather deceptive-by-omission , the ministry of health and family welfare appears to imply that manufacturing NSQ drugs is not a serious offence. But that is simply not true. Below is a list of judgements of prosecutions under section 27(d), along with links to the text of actual judgements, which will illustrate the kind of serious drug quality cases prosecuted by drug inspectors in India under section 27(d) as NSQ drugs:
The accused was prosecuted, under section 27(d), for the alleged offence of manufacturing ampicillin injections which, according to the Drug Testing Laboratory in Thiruvananthapuram, had allegedly “failed to comply with the test for bacterial endotoxin, test for sterility, test for iodine absorbing substances and assay as specified in Indian pharmacopoeia”.
An injection that fails the test for sterility and which contains bacterial endotoxins can have very serious implications for a patient’s health.
The accused were prosecuted under section 27(d) for the alleged offence of manufacturing amoxycillin trihydrate with clavulanate potassium dispersible tablets which, according to government analyst in the Drug Testing Laboratory, had allegedly failed quality testing because only 2.2 mg of clavulanic acid was found in the tablet as against the 28.5 mg declared on the label.
Clavulanic acid inhibits certain enzymes and thereby enhances the antibacterial properties of antibiotics like Amoxycillin by preventing its enzymatic destruction. Needless to say, the effect of the antibiotic will be muted because of the lack of adequate Clavulanic acid in the drug formulation.
The accused were prosecuted under section 27(d) for the offence of manufacturing an azithromycin formulation which tested for only 25.69 mg of the antibiotic, despite the labelling which stated that it contained 200 mg of the active ingredient. The company pled guilty after fighting the case for six years. If such a formulation was administered to a patient suffering from a life-threatening infection, the patient could have died because of a lack of therapeutic effect.
The accused were prosecuted under section 27(d) for the alleged offence of manufacturing serratiopeptidase tablets which were declared to be NSQ by the Drugs Control Laboratory, Hyderabad because the tablet allegedly contained only 7.73 mg as opposed to the 15 mg advertised on the labelling. Serratiopeptidase is an enzyme used for reducing inflammation; as a remedy for pain relief and swelling, mainly in post-operative wounds and inflammatory diseases. The lack of a sufficient active ingredient means that the patient will not get the expected pain relief, which depending on the condition of the patient can lead to serious health complications.
The accused were prosecuted under section 27(d) and pled guilty for the offence of manufacturing an azithromycin formulation which, according to the Central Drug Laboratory, Kolkatam contained only 13.88 percent of the total active ingredient advertised on the label. Once again, a patient suffering from a life-threatening infection can die if administered a broad-spectrum antibiotic that does not contain the advertised amounts of the active ingredient.
As should be obvious from a reading of the above cases, NSQ drugs can have serious health implications ranging from infections to death due to failure of treatment. The government is being dishonest in portraying the manufacture of this category of defective drugs as a minor offence and hence punishable with a mere fine and not imprisonment. Pharmaceutical companies causing hurt to patients because of their negligence, should be punished with the full force of the law and this should include the possibility of imprisonment.
Update at 7 pm, Aug 4: Those accused in offences under section 27(d) can escape jail time upon payment of a fine of Rs 20,000, not Rs 5 lakh. This has been corrected. The error is regretted.
The writers are co-authors of The Truth Pill: The Myth of Drug Regulation in India published by Simon & Schuster, 2022.