Jan Aushadhi Encyclopedia Part 10: Regulatory Framework & Compliance

Operation of a Jan Aushadhi Kendra (JAK) is not just a business agreement; it is a strictly regulated healthcare activity governed by the same laws that apply to any private pharmacy in India.

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1. Compliance with the Drugs & Cosmetics Act, 1940

Every Jan Aushadhi Kendra must operate in strict accordance with the Drugs and Cosmetics Act, 1940, and the Drugs and Cosmetics Rules, 1945.

• The Retail Drug License: Before selling a single pill, every store owner must obtain a valid Retail Drug License (Form 20/21) from the State Drug Controller (SDC).
• Qualified Supervision: As per the Act, no scheduled medicine can be sold without the physical presence of a Registered Pharmacist. PMBI conducts surprise inspections to ensure that the pharmacist listed in the application is actually working at the counter.

2. Pricing Compliance: DPCO Alignment

The medicines sold at Jan Aushadhi Kendras are also subject to the Drugs (Prices Control) Order (DPCO).

• Fixed MRP: The MRP on Jan Aushadhi products is fixed by the PMBI and cannot be changed or overcharged by the store owner.
• Transparency: Every store is required to provide a computerized bill for every transaction. This bill acts as the legal record for pricing compliance.

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3. The “Jan Aushadhi” Trademark & Branding

The name and logo of “Jan Aushadhi” and “PMBJP” are registered trademarks of the government.

• Exclusive Branding: A Kendra operator cannot sell private branded medicines alongside Jan Aushadhi medicines without specific prior permission (though currently, the model is strictly for PMBJP products).
• Signage Rules: PMBI provides a standardized branding guide. Every store must feature the PMBJP logo, the Prime Minister’s photo (as per the scheme guidelines), and specific posters explaining the benefits of generic medicines.

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4. Quality Recalls & Liability

In the rare event that a batch of medicine is declared NSQ (Not of Standard Quality) by an NABL lab after it has reached the store:

• Immediate Suspension: The store owner receives an automated alert through the SAP system to immediately stop the sale of that batch.
• Recall Protocol: The owner must return the unsold stock to the regional warehouse. If any has been sold to patients, the store must attempt to contact those patients as per the standard pharmacovigilance protocols.
• Legal Liability: Since the quality is guaranteed by the PMBI-tested procurement process, the store owner is generally protected as long as they have followed proper storage guidelines (like maintaining the refrigerator for cold-chain drugs).

5. Ethical Guidelines: No “Cut” Culture

Jan Aushadhi Kendras are strictly prohibited from engaging in “unethical” sales practices:

• No Commissions: Operators cannot pay “cuts” or commissions to doctors for prescribing generic medicines.
• Rational Use: Pharmacists are trained to encourage “Rational Use of Drugs,” ensuring that patients only buy what is prescribed and necessary.

Summary

The regulatory framework ensures that while Jan Aushadhi medicines are affordable, they are sold with the highest level of legal and ethical accountability. It is a system that protects the patient as much as it empowers the entrepreneur.

In Part 11, we look at the Roadmap for 2026-2030: what is “Jan Aushadhi 2.0”?

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Next: Part 11 - Roadmap 2026-2030: The Vision for Jan Aushadhi 2.0