Pharma Sector – Drug Pricing, NPPA, FDC, Generics, etc.

Drugs, Medical Devices and Cosmetics Bill 2022

Note4Students

From UPSC perspective, the following things are important :

Prelims level : Schedule H drugs

Mains level : Paper 3- E-commerce for medical drug

Context

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.

Major provisions of the Bill

 1] E-commerce for medical drugs

  • Presently, online sales of medicines account for a fraction of the total pharma sales in India but are forecast to grow exponentially.
  • The first major feature in the new Bill that affects consumers relates to e-commerce.
  • Like all online shopping, the consumer gets the advantage of discounts and the comfort of shopping from home.
  • In normal times, e-commerce can surmount three uniquely Indian disadvantages.
  • Storage condition: 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.
  • Compliance with regal provision: 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 reduce.
  • 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.
  • Concern: Shopping for medical drugs on the internet 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.
  •  A greater focus on medical devices: 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.
  • Provision for advisory board: 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.

Issues not addressed in the Bill

  • Mismanagement of trade: What the Bill does not address is the need to stop the continued mismanagement of the wholesale and retail drugs trade in India.
  • Requirements for drug license not changed: 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.
  •  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.

Way forward

  • There is need for ensuring digitisation of procurement, inventory control and accountability for dispensing drugs into a digital trail.

Conclusion

The debate should not be between e-commerce and retail sale. It should be between being compliant and non-compliant.

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