A draft law to replace the 1940 Drugs and Cosmetics Act with a Drugs, Medical Devices and Cosmetics Bill 2022 was uploaded by the Union health ministry in early July, seeking public comments and objections, within 45 days. The primary objective of any drug law is to ensure that the medical products sold in a country are safe, effective and conform to prescribed quality standards. This article addresses how the new law could help consumers but what more is required.
The first major feature in the new Bill that affects consumers relates to e-commerce. The regulatory cover will come when the rules are notified but the inclusion of a provision in the Bill is reassuring. Presently, online sales of medicines account for a fraction of the total pharma sales in India but are forecast to grow exponentially. The traditional, retail chemist sector has been the mainstay for the population but has generally been unorganised. The sale of substandard, even counterfeit, drugs — particularly in smaller towns and villages — remains widespread.
There are several pros and cons concerning online sales. Like all online shopping, the consumer gets the advantage of discounts and the comfort of shopping from home. During Covid, e-pharmacy platforms were promoted by government digital platforms, so the experience of regulating the sector is available. In normal times, e-commerce can surmount three uniquely Indian disadvantages The first relates to climatic conditions, which require medicines to be stored at below 30 degrees Celsius and 70 per cent relative humidity — unattainable in most of India. It can mandate establishing a back-end brick and mortar store for drug supply having good storage conditions. This is what happens in all countries the world over that allow e-commerce. It can encrypt all transactions otherwise impossible to track.
The second advantage of e-commerce could be fulfilling a legal requirement — providing a bill to the consumer and retaining one copy bearing the batch numbers and expiry dates of the drugs. In addition, the practice of accessing prescription drugs over-the-counter would abate. There are presently over 540 Schedule H drugs that require a doctor’s prescription and the fact that they can be easily accessed over-the-counter is well known. In the case of e-commerce, registration of a pharmacy can require enrollment with the central and state drug control organisations and the practice of uploading a prescription from a registered medical practitioner can be enforced. Some Indian e-pharmacy outlets have begun facilitating getting a prescription after tele-consultations.
The flipside of shopping for medical drugs on the internet is that it could encourage overuse or incomplete use of drugs, increase dependency on habit-forming medicine — for example, sleep-inducing drugs or self-medication with products for weight loss, male enhancement, even treating mental illness — which is fraught with dangerous consequences. The rules can easily exclude identified medication or make access stringent. On balance, however, the advantage lies in facilitating e-commerce for medical drugs.
The draft law also proposes according a greater focus on medical devices, which include thousands of engineered apparatuses like stents, joint implants, pacemakers, catheters, etc, which require quality regulation. Rules for medical devices were notified in 2017 but now it is proposed to establish a statutory Medical Device Technical Advisory Board, with experts from the fields of atomic energy, science and technology, electronics, and related fields like biomedical technology to guide the process. This is a welcome move that will bring in the required expertise.
What the Bill does not address is the need to stop the continued mismanagement of the wholesale and retail drugs trade in India – a nightmare for every state drugs controller. The problem ranges from Bhagirath Palace in Chandni Chowk, Delhi — Asia’s biggest drug wholesale market some say — or the unqualified practitioner at the other end of the spectrum, jabbing steroids into poor and uneducated patients. In the past, raids — whether at drug wholesale hubs or small pharmacies — have unearthed counterfeit and spurious drugs but have resulted in little deterrence. Drugs move from the manufacturers to the carrying and forwarding agents who, in turn, assign the drugs to “registered wholesalers or stockists” located in Bhagirath Palace or other state drug wholesale hubs. Rule 64 (2) of the Drugs and Cosmetics Rules 1945 lays down that a wholesale drug licence can be given to a qualified pharmacist or one who has passed the matriculation examination or its equivalent or a graduate with one year’s experience in dealing with drug sale. This is a relic from 80 years ago. When the country is reported to have over 7,00,000 pharmacists, this anachronism must be discarded.
In fairness, it was sought to be corrected in December 2016 by deleting the above clauses from the Drugs Rules and a draft was even gazetted in 2016 on the recommendations of the health ministry’s Drugs Consultative Committee headed by the Drugs Controller General (India) and subsequently by the Drugs Technical Advisory Committee headed by the Director General of Health Services. But after seven years, the eligibility criteria continue to allow a matriculate or an ordinary graduate (albeit with a few years experience,) to get a licence as a wholesaler or stockist. It is essential to introduce a binding and enabling provision to only licence qualified pharmacists and put the safety of millions of citizens before the self-preservation of a few thousand wholesalers and stockists.
And that brings me to the consumer side of the sale of drugs, particularly in small pharmacies. My research and field study — “Unqualified Medical Practitioners in India”, published by Shiv Nadar University in 2017 — describes how easily prescription drugs can be purchased from a medical shop where a proxy licencee provides legal cover in absentia to the shop owner. That he himself possesses zero knowledge about pharmaceuticals has not bothered any state regulator. This must be stopped. Unless digitisation of procurement, inventory control and accountability for dispensing drugs gets encrypted into a digital trail, random raids and inspections will serve no purpose.
The debate should not be between e-commerce and retail sale. It should be between being compliant and non-compliant.
The writer is former secretary, Ministry of Health. Views are personal
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