The factory of the digital pharmacist
A law Project to replace the Medicines and Cosmetics Act 1940 with a Medicines, Medical Devices and Cosmetics Bill 2022 was posted online by the Union Department of Health in early July, seeking comments and public objections, within 45 days. The main objective of any drug law is to ensure that medical products sold in a country are safe, effective and meet prescribed quality standards. This article explains how the new law could help consumers, but what more is needed.
The first major feature of the new bill that affects consumers concerns e-commerce. The regulatory cover will come when the rules are notified but the inclusion of a provision in the bill is reassuring. Currently, online drug sales are only a fraction of total pharmaceutical sales in India, but are expected to grow exponentially. The traditional retail pharmacy sector has been the mainstay of the population, but it has generally been unorganized. The sale of substandard and even counterfeit medicines, especially in small towns and villages, remains widespread.
There are several advantages and disadvantages regarding online sales. Like all online purchases, the consumer benefits from reductions and the comfort of shopping at home. During Covid, e-pharmacy platforms have been promoted by government digital platforms, so industry regulation experience is available. In normal times, e-commerce can overcome three drawbacks unique to India. The first is climatic conditions, which require medicines to be stored at less than 30 degrees Celsius and 70% relative humidity, which is unreachable in most of India. It can mandate the establishment of a main brick-and-mortar store for the supply of medicines with good storage conditions. This is happening in every country in the world that allows e-commerce. It can encrypt all otherwise untraceable transactions.
The second advantage of e-commerce could be to meet a legal requirement: provide an invoice to the consumer and keep a copy bearing the batch numbers and expiry dates of the drugs. Additionally, the practice of accessing over-the-counter prescription drugs would decrease. There are currently over 540 Schedule H drugs that require a doctor’s prescription and the fact that they are readily available over the counter is well known. In the case of e-commerce, registration of a pharmacy may require registration with central and national drug control organizations and the practice of uploading a prescription from a licensed physician may be applied. Some Indian online pharmacies have started making it easier to get a prescription after teleconsultations.
The flip side of buying drugs over the Internet is that it could encourage overuse or incomplete use of drugs, increase reliance on habit-forming drugs – for example, drugs that induce sleeping or self-medicating with products for weight loss, male enhancement, even treating mental illness – which is fraught with dangerous consequences. Rules can easily exclude identified drugs or restrict access. Overall, however, the benefit lies in facilitating e-commerce of medicines.
The bill also proposes to put more emphasis on medical devices, which include thousands of technical devices such as stents, joint implants, pacemakers, catheters, etc., that require regulation of the quality. The medical device rules were notified in 2017, but it is now proposed to create a statutory technical advisory committee on medical devices, made up of experts from the fields of atomic energy, science and technology, electronics and related fields such as biomedical technology to guide the process. This is a welcome decision that will provide the required expertise.
What the bill fails to address is the need to end the continued mismanagement of the wholesale and retail drug trade in India – a nightmare for all state drug controllers. The problem ranges from Bhagirath Palace in Chandni Chowk, Delhi – Asia’s largest wholesale drug market, some say – or the unskilled practitioner at the other end of the spectrum, who injects steroids into poor and destitute patients. instruction. In the past, raids – whether at wholesale drug centers or small pharmacies – have uncovered counterfeit and falsified medicines, but have had little deterrent effect. Drugs move from manufacturers to transporters and freight forwarders who in turn assign the drugs to “registered wholesalers or dealers” located at Bhagirath Palace or other drug wholesale centers in the state. Rule 64(2) of the Medicines and Cosmetics Rules 1945 states that a wholesale medicine license may be granted to a qualified pharmacist or a person who has passed the registration examination or its equivalent or to a graduate with one year of experience in the field of drug sales. It’s a relic from 80 years ago. While the country has more than 7,000,000 pharmacists, this anachronism must be dismissed.
In fairness, it was asked to be corrected in December 2016 by removing the above clauses from the drug rules and a draft was even published in 2016 on the recommendations of the Ministry of Health’s Drug Advisory Committee headed by the Controller General of Drugs (India) and subsequently by the Drug Technical Advisory Committee chaired by the Director General of Health Services. But after seven years, the eligibility criteria continue to allow an ordinary graduate or graduate (albeit with a few years of experience) to obtain a wholesaler or stockist license. It is essential to introduce a binding and enabling provision to license only qualified pharmacists and put the safety of millions of citizens ahead of the self-preservation of a few thousand wholesalers and resellers.
And that brings me to the consumer side of selling drugs, especially in small pharmacies. My research and field study – “Unqualified Medical Practitioners in India”, published by Shiv Nadar University in 2017 – describes the ease with which prescription drugs can be purchased from a medical store where a proxy licensee provides legal coverage in absentia to the store owner. The fact that he himself has no knowledge of pharmaceuticals has not bothered any state regulator. This must be stopped. Unless digitization of purchases, inventory control, and accountability for drug distribution are encrypted in a digital trail, random raids and inspections will serve no purpose.
The debate should not be between e-commerce and retail. It should be between conforming and non-conforming.
The author is a former secretary of the Ministry of Health. Views are personal