Draft Drugs, Medical Devices and Cosmetics Bill 2022: The making of the digital pharmacist

Source: The post is based on an article “Draft Drugs, medical Devices and Cosmetics Bill 2022: The making of the digital pharmacist” published in the Indian Express on 28^th July 2022.

Syllabus: GS 2 Government Policies and Interventions for Development in various sectors and Issues arising out of their Design and Implementation.

Relevance: Draft Drugs, medical Devices and Cosmetics Bill 2022

News: Recently, the Union Health Ministry has announced the Drugs, Medical Devices and Cosmetics Bill 2022, for seeking public comments and objections, within a period of 45 days.

About the bill

The bill is proposed to replace the 1940 Drugs and Cosmetics Act. The primary objective is to ensure that the medical products sold in a country are safe, effective and conform to prescribed quality standards.

It proposes a greater focus on quality of medical devices,

It is proposed to establish a statutory Medical Device Technical Advisory Board. The board will have experts from the fields of atomic energy, science and technology, electronics, and related fields like biomedical technology to guide the process.

What are the advantages of online sale of medical products?

(1) Like all online shopping, the consumer gets the advantage of discounts and the comfort of shopping from home.

(2) In normal times, e-commerce can address three uniquely disadvantages prevalent in Indian market

First, it can meet climatic conditions, which require medicines to be stored at below 30 degrees Celsius and 70% relative humidity, which is unattainable in most parts of India.

Second, it can mandate the back-end brick and mortar store to have good storage conditions for drug supply.

Third, further, e-commerce is useful to encrypt all transactions otherwise impossible to track.

(3) The e-commerce could be fulfilling a legal requirement: (a) providing a bill to the consumer and retaining one copy bearing the batch numbers and expiry dates of the drugs, and (b) it can abate the present practice of accessing prescription drugs over-the-counter as these drugs require a doctor’s prescription.

(4) In the case of e-commerce, registration of a pharmacy can require enrolment with the central and state drug control organisations.

(5) This would enforce the practice of uploading a prescription from a registered medical practitioner.

What are the disadvantages of online sale of medical products?

(1) It could encourage overuse or incomplete use of drugs, increase dependency on habit-forming medicine, like sleep-inducing drugs or self-medication with products for weight loss, male enhancement, even treating mental illness.

What more is required to be done?

There is the need to stop the continued mismanagement of the wholesale and retail drugs trade in India. For example, the Bhagirath Palace in Chandni Chowk, Delhi is Asia’s biggest drug wholesale market. It is also classified as the hub of unqualified practitioner at the other end of the spectrum.

However, the Rule 64 (2) of the Drugs and Cosmetics Rules 1945 mandates 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. But the eligibility criteria continue despite recommendation for deletion from 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.

The sale of substandard, even counterfeit, drugs remain widespread in India, particularly, in smaller towns and villages. The drug wholesale hubs or small pharmacies sell counterfeit and spurious drugs to the poor patients.