The Jan Vishwas Bill, 2023, passed by Lok Sabha on July 27, is in the news for its lenient approach to the crime of manufacturing “not of standard quality” drugs. But comparatively less attention is being paid to the adverse impact that the legislation will have on an equally serious issue, which is the regulation of pharmacies that have a key role to play in India’s drug supply.
To begin with, pharmacies must ensure they buy drugs from only licensed distributors and store those drugs in suitable conditions until dispensed to patients who present valid prescriptions. Pharmacies also need to maintain extensive records of the purchase and sale of drugs to ensure supply chain integrity.
To dispense these drugs, pharmacies require a trained pharmacist who is able to read the prescription and provide the patient with the correct brand of drug, if not the most affordable generic version of the drug prescribed by the doctor. This is no simple task in a country like India where brand names of entirely different drugs formulations can be similar or same, as evidenced by the record levels of pharmaceutical trademark litigation in India.
Ideally, the pharmacist should also counsel the patient on how to store the drug, how to administer them and the possible side-effects or adverse reactions associated with it. Each of these functions described above are critical to either maintaining drug quality and ensuring patient safety.
Given the complexity of running pharmacies, both the Pharmacy Act, 1948, and the Drugs & Cosmetics Act, 1940, require pharmacies to employ a registered pharmacist.
Section 42 of the Pharmacy Act does this by giving the profession of “registered pharmacists” (who are regulated by the Pharmacy Council of India) a monopoly over “compound, prepare, mix, or dispense any medicine on the prescription of a medical practitioner”. The only other profession that can practice this profession are registered medical practitioners.
The history of Section 42 is long and tortuous. Originally, when enacted in 1948, Parliament delegated to the state government the power to bring Section 42 into effect on a date of their choosing. This leeway was likely given to state governments because pharmacy colleges had to be set up to train a cadre of professional pharmacists.
When, almost 30 years later, most states failed to notify the provision into law, Parliament amended the Pharmacy Act during the Emergency in 1976 to bring Section 42 into effect in all states in a five-year period. When this period expired in 1981 and in the face of strikes by chemists and druggists, Parliament provided another three-year extension. As a result, Section 42 came into effect only in 1984.
Any violation of Section 42 is punishable with imprisonment for a term that may extend to six months or with a maximum fine of Rs 1,000. A criminal punishment, including a jail ,term is completely justified for the violation of Section 42 because dispensing drugs is often a question of life and death for patients. A person not trained as a pharmacist is capable of causing death or at least failure of treatment by failing to store drugs properly or by dispensing the wrong drug.
Despite being in effect across India since 1984, we have not been able to find many legal cases that have invoked Section 42 since most prosecutions of pharmacies for running without a registered pharmacist actually take place under the Drugs & Cosmetics Act, 1940.
This is because one of the conditions of a pharmacy licence under Rule 65 of the Drugs & Cosmetics Rules, 1945 is the mandatory presence of a registered pharmacist to supervise the dispensing of drugs. The violation of Rule 65 is prosecuted under Section 18(c) read along with Section 27(d) of the Drugs & Cosmetics Act. The punishment for a violation is a maximum of two years imprisonment and a minimum of one year, with special exceptions and a fine of Rs 20,000.
Despite the employment of pharmacists being mandated under two different legislations with criminal penalties, many pharmacies brazenly violate this requirement by operating without employing any registered pharmacists.
From Maharashtra to Telangana to West Bengal to Tamil Nadu, there have been complaints and often admissions by drug inspectors that hundreds of pharmacies are being run without the presence of a registered pharmacist. As per the Pharmacy Council of India, the reason for this is not the shortage of pharmacists but a reluctance by proprietors of pharmacies to pay the higher salaries often demanded by the registered pharmacists when compared to a neighbourhood worker.
But why are existing criminal penalties under the law not deterring such behaviour? The answer, in our opinion, is first, poor prosecutions by drug inspectors under the Drugs & Cosmetics Act leading to acquittals and second, leniency by most criminal courts in India who often allow the owners of pharmacies to escape the minimum of one year prison time in Section 27(d) on the payment of the penalty of Rs 20,000 by invoking the “special reasons exception” in the provision.
Take, for example, the case of State vs Indulal Bogilal Shaha, where the owner of a pharmacy pled guilty before the Court of the Judicial Magistrate First Class, Raigad, to running a pharmacy without a registered pharmacist. The court merely sentenced the owner to “simple imprisonment till the rising of the court”, allowing him to leave once the judge rose from the bench and a fine of Rs 20,000.
When the law is already so lenient, it is surprising for the government to propose via the Jan Vishwas Bill 2023, the decriminalisation of both Section 42 of the Pharmacy Act, 1948, and Section 27(d) of the Drugs & Cosmetics Act, 1940. The bill proposes amending Section 42(2) to delete the imprisonment clause and replace it with a mere fine of Rs 1 lakh.
The bill also proposes making Section 27(d) compoundable on payment of Rs 20,000 meaning that if the owner of the pharmacy is ready to cough up Rs 20,000, they do not have to go to prison. Apart from the obvious question as to why the same offence is punishable with Rs 1 lakh under one law and Rs 20,000 under a different law, is the moral bankruptcy of allowing businesses engaging in harmful behaviour towards patients to escape without any prison time.
Regrettably, this discussion does not end with pharmacies running without pharmacists since Section 27(d) is also the provision invoked in prosecutions of pharmacies running in violations of the licence conditions specified in Rule 65 of the Drugs & Cosmetics Rules. This includes failure to maintain adequate storage conditions of drugs, the failure to maintain records of purchase and sale, the act of dispensing schedule H and X drugs without a prescription, maintenance of a prescription register.
Violations of these various conditions in Rule 65 can have a variety of harmful implications for public health. For example, drugs not properly stored will degrade. A failure to maintain records will make it impossible for drug inspectors to conclusively establish the chain of supply to the manufacturer in cases where the manufacturer of not of standard quality drugs are being prosecuted. The failure to dispense drugs only as per prescriptions will lead to prescription abuse leading to either drug addiction or perhaps increased antibiotic resistance. The failure to maintain an accurate prescription register will make the already difficult task of drug recalls impossible.
While the government does not release any data on convictions under this law, we have seen our fair share of cases ending in acquittal or extremely lenient sentences where the accused escapes any prison time.
Take for example the case of State of Maharashtra vs Mahendra Champala Jain, Proprietor of K.M. Medical Stores before the Court of Chief Judicial Magistrate, Pune where the prosecuting drug inspector failed to prove a single charge against the accused. This included serious charges like improper storage of drugs, failure to maintain purchase records, manipulation of records etc.
An example of a case which ended in conviction but a lenient sentence is the case of State vs Dhinakaran, Proprietor of Dheena Medicals before the Court of the Chief Judicial Magistrate, Chengalpattu. The owner of the pharmacy pled guilty to running the pharmacy in absence of the registered pharmacist, that prescription drugs were sold without the presence of the registered pharmacist and that the prescription register was not maintained properly.
Despite these serious charges, the court sentenced the accused to “simple imprisonment till the rising of the court” and a paltry fine of Rs 25,000. This is a common outcome in prosecutions of pharmacies being run without registered pharmacies or maintenance of records.
All of the above are violations that have serious implications for public health and while the existing law is implemented poorly or leniently, it still provides for some deterrent because there is a fear of imprisonment.
To replace imprisonment with a mere fine of Rs 20,000 will dramatically increase the risk-taking behaviour of pharmacies to the detriment of public health in India. India should be taking steps to tighten regulation of pharmacies in order to improve public health outcomes, instead of relaxing punishments to the extent done through the Jan Vishwas Bill, 2023.
The writers are co-authors of The Truth Pill: The Myth of Drug Regulation in India published by Simon & Schuster, 2022.
Corrections and clarifications: This article has been edited to reflect the amount of the fine under Section 27(d).