The Drugs and Cosmetics Act, 1940, along with the Rules of 1945, forms the backbone of India’s pharmaceutical regulatory system. This legal structure ensures that drugs manufactured, sold, or distributed in India meet strict standards of identity, purity, safety, and quality. Unit 2 dives deeper into the critical schedules under the Act, rules governing drug sales, labeling and packaging regulations, and the administrative bodies responsible for enforcement. Presented in a news-style educational format, this article helps students grasp the complexity and significance of pharmaceutical law.
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Understanding Key Schedules Under the Drugs and Cosmetics Rules, 1945
Schedules G and H
Schedule G includes drugs that require medical supervision. Labels must clearly state: “Caution: It is dangerous to take this preparation except under medical supervision.”
Schedule H lists prescription-only medicines, including antibiotics and hormonal preparations. These cannot be sold without a written prescription from a registered medical practitioner.
Schedules M and N
Schedule M lays down Good Manufacturing Practices (GMP) for pharmaceutical units, covering equipment, sanitation, quality control, production processes, and documentation. It ensures drug manufacturing meets global standards.
Schedule N provides detailed requirements for pharmacies, including storage facilities, premises layout, and equipment, ensuring proper handling and dispensing.
Schedules P, T, U, and V
Schedule P specifies the minimum shelf-life of drugs and conditions for storage.
Schedule T governs Ayurvedic, Siddha, and Unani manufacturing units, prescribing GMP-like standards for traditional medicines.
Schedule U outlines mandatory records and registers for manufacturing, ensuring transparency and traceability.
Schedule V specifies standards for patent and proprietary medicines, ensuring consistent formulation and labeling.
Schedule X and Schedule Y
Schedule X regulates narcotic and psychotropic substances, demanding stricter recordkeeping and secure storage. These drugs require special prescription forms.
Schedule Y governs clinical trials, including ethical requirements, phases of trials, responsibilities of sponsors, and data documentation. This schedule is the foundation of India’s modern drug development framework.
Part XII B, Schedule F & DMR (OA)
Part XII B focuses on labeling and packing of cosmetics.
Schedule F provides standards for biological products like vaccines, sera, and toxins.
DMR (OA) refers to standards and requirements for ophthalmic preparations, ensuring sterility and preservative compliance.
Sale of Drugs: Wholesale, Retail, and Restricted Licenses
Wholesale Sale of Drugs
Wholesale dealers must obtain a wholesale license, ensuring adequate storage, qualified staff (often a competent person with relevant experience), and proper recordkeeping. Wholesalers cannot sell Schedule X drugs without proper documentation.
Retail Sale of Drugs
Retail pharmacies require a retail drug license and must operate under the supervision of a registered pharmacist. Retailers must dispense Schedule H and X drugs only against valid prescriptions and maintain purchase and sale records.
Restricted Licenses
Restricted licenses apply to small outlets selling OTC drugs (non-prescription). They do not require a full-time pharmacist but may sell only limited categories of drugs.
Offences and Penalties
Unauthorized sale, dispensing without prescription, or selling misbranded/adulterated drugs can result in imprisonment, license cancellation, and heavy fines. These penalties ensure accountability throughout the supply chain.
Labeling and Packaging Requirements Under the Act
General Labeling Requirements
Drug labels must include:
Name of the drug
Active ingredients with strengths
Batch number and manufacturing license number
Date of manufacture and expiry
Storage conditions
Manufacturer’s address
Schedule warnings (e.g., Schedule H caution)
These requirements protect consumers and healthcare providers by ensuring transparency and traceability.
Specimen Labels and Cosmetic Labeling
Specimen labels demonstrate correct label placement and content. Cosmetics must include ingredient names, warnings, net content, and manufacturer details.
Permitted colors for drugs and cosmetics must comply with Bureau of Indian Standards (BIS) specifications to prevent toxicity or allergic reactions.
Offences and Penalties
Mislabeling, incomplete labeling, false therapeutic claims, or using non-permitted colors can lead to penalties, including product seizure, fines, and manufacturer prosecution.
Administration of the Act and Rules: Key Regulatory Bodies
Drugs Technical Advisory Board (DTAB)
DTAB is the apex advisory body that reviews technical matters related to drug standards and recommends amendments. It includes experts from pharmacology, medical sciences, and drug control administration.
Central Drugs Laboratory (CDL)
CDL serves as the national drug testing laboratory, analyzing samples sent by drug inspectors and verifying compliance with standards for vaccines, sera, diagnostic kits, and other pharmaceutical products.
Drugs Consultative Committee (DCC)
The DCC ensures uniform enforcement of the Act across India by coordinating between the Central Government and State Drug Control Departments.
Government Drug Analysts
Appointed analysts evaluate drug quality through laboratory testing. Their reports are used as evidence in legal proceedings related to drug quality violations.
Licensing Authorities and Controlling Authorities
State licensing authorities issue manufacturing, sale, and distribution licenses. Controlling authorities supervise drug inspectors and ensure compliance with legal provisions.
Drugs Inspectors
Drug inspectors play a frontline role by inspecting pharmacies and manufacturing facilities, collecting drug samples, enforcing labeling standards, and identifying violations.