24/03/2026
Why Rule 64 was inacted in drug rules under Drug and cosmetics act 1940.
During the 1930sтАУ1940s:
India faced a flood of substandard, adulterated, and misbranded drugs
There was no structured control over drug sale, storage, or distribution
Many sellers had no scientific knowledge of medicines
Public health risks were alarmingly high due to irrational dispensing
The Chopra Committee (1930тАУ31) highlighted these issues and strongly recommended:
Establishment of drug control laws
Regulation of drug import, manufacture, and sale
Appointment of qualified personnel in drug handling
This ultimately led to:
Enactment of the Drugs and Cosmetics Act, 1940
Framing of the Drugs and Cosmetics Rules, 1945
ЁЯОп Core Intention Behind Rule 64
Rule 64 specifically addresses the qualifications of a тАЬCompetent PersonтАЭ for the sale of drugs.
The primary intentions were:
1. ЁЯза Ensure Scientific Handling of Drugs
Medicines require:
Proper storage conditions
Knowledge of dosage and stability
Understanding of expiry and interactions
ЁЯСЙ Rule 64 ensured that only individuals with relevant education and/or experience could handle such responsibilities.
2. тЪЦя╕П Standardization Across Drug Trade
Before regulation, drug selling was highly unorganized.
ЁЯСЙ Rule 64 aimed to:
Bring uniformity in qualifications
Define minimum competency standards
Avoid arbitrary or unqualified practices
3. ЁЯЫбя╕П Protection of Public Health
The most critical goal was:
Prevent misuse, abuse, and mishandling of medicines
Reduce risks of toxicity, therapeutic failure, and adverse effects
ЁЯСЙ The тАЬCompetent PersonтАЭ acted as a first-line regulatory checkpoint between drugs and patients.
4. ЁЯОУ Recognition of Pharmacy as a Profession
At that time, pharmacy was still evolving as a formal profession in India.
ЁЯСЙ Rule 64:
Reinforced the need for trained pharmaceutical personnel
Supported the emergence of qualified drug handlers
Complemented later developments like the Pharmacy Act, 1948
5. ЁЯПк Regulation of Retail and Wholesale Drug Licenses
Rule 64 was also tied to:
Granting and renewal of drug sale licenses
Ensuring that every licensed premises had a designated responsible person
ЁЯСЙ This created accountability in the drug supply chain
In essence, Rule 64 was framed with a clear and noble vision:
тАЬDrugs must not be treated as ordinary trade goods; they must be handled by individuals who are competent enough to safeguard public health.тАЭ
Why It Still Matters Today
Even today, the spirit of Rule 64 remains:
It defines who is qualified to take responsibility
It ensures minimum professional standards
It acts as a bridge between regulation and safe drug use
However, any dilution of this rule directly challenges its original intent of ensuring competence over convenience.
It is deeply concerning to witness the continuous dilution of educational qualifications and professional experience required for the post of Competent Person under Rule 64 of the Drugs and Cosmetics Act, 1940.
Historically, this provision was designed with a clear intent: to ensure that individuals responsible for handling, dispensing, and managing drugs possess adequate academic training and practical exposure. The role of a competent person is not clericalтАФit is scientific, ethical, and directly linked to patient safety.
However, over the years, amendments and relaxations have gradually lowered the benchmark. What once required a well-qualified pharmacy professional with substantial experience is now being opened to individuals with comparatively minimal or diluted credentials. This shift raises serious questions:
ЁЯФ┤ Are we compromising drug safety for administrative convenience?
ЁЯФ┤ Are we undermining the value of pharmacy education?
ЁЯФ┤ Are we placing public health at risk by weakening regulatory safeguards?
ЁЯУЬ A Look Back: Then vs Now
Earlier frameworks emphasized:
Strong academic grounding in pharmaceutical sciences
Mandatory hands-on experience in drug handling and regulatory compliance
Accountability and ethical responsibility
Today, the trajectory appears to be shifting towards:
Reduced emphasis on specialized education
Relaxed experience requirements
Increased scope for non-pharmacy backgrounds to occupy critical roles
Medicines are not ordinary commoditiesтАФthey are life-saving interventions. we are moving towards polypharmacy, antibiotic resistance, misuse of drugs, irrational combinations in the market.
We have staeted programmes like M.Pharm Pharacy practise, Pharm D. M.pharm DRA , M.pharm Pharmacovigilance.
if not required why are thses courses introduced.
Any compromise in the drug storage, dispensing, or regulatory oversight can have irreversible consequences. The Competent Person acts as a gatekeeper in this system. Weakening this role is equivalent to weakening the entire drug distribution chain.
Dilutiuon of rule 64:
Devalues the rigorous training of pharmacy graduates
Demotivates aspiring professionals
Erodes the identity and authority of pharmacist.
