Last Updated on March 23, 2026 by The Health Master
Rule 64
The Drugs Technical Advisory Board (DTAB) has proposed a significant change to Rule 64 of the Drugs Rules, 1945.
This recommendation was made during the high-level meeting of the DTAB in February 2026.
The DTAB is proposing changes to the qualifications of the “competent person” that is required to manage the sales premises that are licensed for the sale of drugs under either Form 20B or Form 21B.
Understanding the Shift in Rule 64 Qualifications
Currently, there are two competing viewpoints for the qualifications of such a “competent person“. One group of experts recommends that the person in charge of the wholesale premises must be a registered pharmacist.
The alternative viewpoint, however, suggests that a graduate of any scientific degree from a recognized university can qualify for such a position.
Formerly, the Drugs and Cosmetics Rules required that the person in charge of a wholesale drug sales premise must be either a registered pharmacist with a D.Pharm, B.Pharm, or Pharm.D. degree.
However, experts have noted the desirability and accessibility of this qualification for these positions.
Therefore, the DTAB is suggesting that while a registered pharmacist can still qualify for such a position, a science degree graduate can also qualify for such a position if they meet certain requirements.
Related article: DTAB 93rd Meeting Highlights: New Regulatory Reforms for Pharma Sector in India
The New Proposed Eligibility Criteria
According to the DTAB, a “competent person” can be any one of the following:
- A Registered Pharmacist
- A graduate of a science degree from a recognized university, who has:
- At least two years of experience in dealing with drugs
- Completed a six-month online certificate course from authorities like the Pharmacy Council of India (PCI), NIPER, or the Skill Development Council
Comparison: Existing vs. Proposed Rule 64 Requirements
| Feature | Existing Rule 64 (Current) | Proposed DTAB Amendment (2026) |
| Pharmacist Entry | Registered Pharmacist | Registered Pharmacist |
| Science Graduates | Degree + 1 Year Experience | Degree + 2 Years Experience + 6-Month Online Course |
| Matriculate Entry | 10th Pass + 4 Years Experience | Deleted (Phasing out lower qualifications) |
| Certification | None required for graduates | Mandatory Online Certificate (PCI/NIPER) |
Why the Change?
DTAB’s proposed changes to Rule 64 are aimed at creating an updated supply chain of drugs in India while ensuring that the quality, safety, and efficacy of drugs that enter the country is maintained.
Currently, an individual with only a matriculation certificate (completion of the 10th grade) and four years of experience is eligible to manage a drug sales premise licensed under Form 20B or Form 21B.
DTAB feels that the removal of this qualification will improve the supply chain of drugs and ensure that individuals in this field are of a higher standard of education.
The Long Road to Finalization
DTAB began to discuss and propose amendments to Rule 64 as far back as 2015. A draft notification was published in 2016 proposing such amendments to Rule 64.
However, various stakeholders rejected this proposal due to the availability of registered pharmacists for various wholesale premises, especially those located in remote areas of the country.
The Central Government of India consequently asked DTAB to reconsider the proposal.
CDSCO and the Drugs Consultative Committee (DCC) are currently working together to ensure that the rules proposed by DTAB are in accordance with the present state of the pharmaceutical industry in India.
Recently, the DCC has requested a final report from DTAB regarding the changes that will ensure that all states in the Indian union have uniform implementation of these rules.
Also read: Procedure to obtain license for Medical Store / Pharmacy
FAQs
Q. Will this rule apply to retail pharmacies as well?
No. This rule only applies to individuals who are seeking to obtain wholesale licenses for Form 20B or Form 21B. Retail licenses will still require the presence of a registered pharmacist.
Q. Will individuals with licenses under the old Rule 64 be affected by this change?
The DTAB has indicated that this rule will not apply to individuals who are already licensed for wholesale drugs under Form 20B or Form 21B prior to the publication of the final notification that will be published by the government of India.
Q. Which online programs will offer the six-month certification program for science graduates?
DTAB has specifically indicated that science graduates will be able to take online certificate programs from bodies such as the Pharmacy Council of India (PCI), the National Institute of Pharmaceutical Education and Research (NIPER), and the Skill Development Council.
Q. Why is the qualification of an individual who only completes his 10th grade and has four years of experience in the pharmaceutical field being deleted from Rule 64?
DTAB feels that such an individual is not of a suitable standard of expertise in relation to the complex medicines that are available in India’s present supply chain. Therefore, the individual will be required to have at least a science degree and experience in the pharmaceutical field in order to ensure that there are qualified individuals who are managing the supply of drugs in India.
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