Last Updated on October 20, 2024 by The Health Master

Notification

In recent developments, the Ministry of Ayush issued Notification No. GSR 98(E) dated 02nd February 2024, proposing amendments to the Drug Rules 1945.

However, this move has sparked certain suggestions and objections.

This article aims to dissect and analyze the concerns raised against this notification, shedding light on key points that demand attention and reconsideration.

The Context: Drugs Cosmetic and Medical Devices Bill 2023

1. Draft Bill’s Availability for Public Comment
   • The draft bill of Drugs Cosmetic and Medical Devices Bill 2023 was publicly available for stakeholders’ comments and is presently under consideration by the Parliament.
   • Rules under the parent act, Drugs and Cosmetic Act, should not precede changes in the parent act itself.
2. Rules as Enablers of the Parent Act
   • Rules are designed to give effect to the intent of the parent act, i.e., Drugs and Cosmetics Act.
   • Alterations in rules during the parliamentary consideration of the parent act may disrupt the legislative harmony.
3. Enabling Provisions in the Parent Act
   • Every rule should have an enabling provision in the parent act, emphasizing that suggested changes should align with the parent act, which is currently under parliamentary scrutiny.
4. Validity of Rules without Enabling Provision
   • Rules lacking an enabling provision in the parent act are deemed null and void.
   • Proposals for rule changes are baseless when the parent act is under parliamentary review.

Specific Concerns Regarding Proposed Amendments

5. Amendment in Rule 157: Class 2 Substitution
   • The proposed substitution raises concerns about the qualification requirement for Ayurveda, Siddha, Sowa Rigpa, or Unani drug manufacturing.
   • The suggested change is deemed against the principles of law and natural justice, posing a potential threat to pharmacy graduates’ knowledge and job prospects.
   • Bifurcation between Ayurvedic and allopathic pharmacy graduates is deemed inappropriate, considering the comprehensive syllabus covering pharmaceutical analysis, industrial pharmacy, pharmaceutics, and phytochemicals.
6. Impact on Pharmacy Graduates
   • The proposed amendment threatens to diminish job prospects for pharmacy graduates.
   • B. Pharmacy is advocated as the sole qualification for manufacturing, testing, etc., of drugs of any type, and the proposed changes should not be entertained.

Crucial points for consideration

Two crucial points for consideration:

1. Delay in Amendments
   • Proposed amendments should not be considered until the parent Drugs Cosmetic and Medical Device Bill is passed by the Parliament.
2. Qualification Criteria
   • The qualification for drug manufacturing and testing should remain B. Pharmacy, as it encompasses the necessary knowledge for all types of drug-related activities.

Also read: Changes in Homoeopathy Drug Regulations

Conclusion

In conclusion, the objections and suggestions raised against Notification No. GSR 98(E) underscore the need for a thorough review and reconsideration.

The proposed amendments, particularly those affecting the qualification criteria, demand careful consideration to prevent adverse consequences for pharmacy graduates and maintain the integrity of the pharmaceutical industry.

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