How the Schedules Came into Existence

A long time ago, before India’s independence, there were no proper laws to control medicines. Anyone could sell any drug, in any form, with false claims. Some medicines were fake, harmful, or even poisonous, and people had no way to know what was safe. This led to many cases of illness, addiction, and even deaths due to unregulated drugs.

Seeing this problem, the British Government in India formed a committee called the Drugs Enquiry Committee in 1930, headed by R.N. Chopra. Their job was to study how medicines were being made and sold in India. The committee found that there was no system to classify or control drugs, and that strong or habit-forming medicines were being sold freely without a doctor’s prescription.

To solve this, they suggested that drugs should be divided into categories, each with specific rules — for example, some should be sold only on a doctor’s prescription, some should have warning labels, and some should meet manufacturing standards.

When the Drugs and Cosmetics Act was passed in 1940, these categories were written into law as “Schedules.” Each Schedule contained different types of rules — for manufacturing (Schedule M), labeling (Schedule G), prescription-only drugs (Schedule H), and so on.

Since then, Schedules have become the heart of pharmaceutical law, ensuring that only safe, effective, and properly regulated medicines reach the people.

Schedules are follows:-

Schedules in Pharmaceutical Jurisprudence

Schedule	Guideline / Rules Description
A	Proforma for the application for licenses, issue and renewal of licenses, and for sending memoranda under the Act.
B	Fees for analysis of drugs or cosmetics payable to the Central Drug Laboratories or other government laboratories.
C	List of biological and immunological products, antibiotics, ophthalmic preparations, ointments, and parenteral products.
C(I)	List of biological-origin drugs like alkaloids, hormones, vitamins, and antibiotics intended for oral use.
D	Exemptions granted to drugs and drug importers from certain import requirements.
E	List of poisonous substances for which special labeling and handling rules are required.
E(I)	List of poisonous substances under Ayurvedic, Siddha, and Unani systems of medicine.
F	Standards and regulations for the manufacture, testing, and labeling of human biological products such as sera and vaccines.
F(I)	Rules regarding the manufacture, testing, and labeling of veterinary biological products.
F(II)	Standards prescribed for surgical dressings.
F(III)	Standards for umbilical tapes.
FF	Standards for ophthalmic preparations.
G	List of drugs that must be labeled with the warning “To be sold by retail on the prescription of a registered medical practitioner only.”
H	List of prescription drugs restricted to sale on prescription by a registered medical practitioner.
H1	List of antibiotics, anti-TB, and habit-forming drugs requiring mandatory prescription record maintenance by the pharmacist.
J	List of diseases and conditions that cannot be claimed to be prevented or cured by drugs.
K	Exemptions granted to certain drugs (like soaps, disinfectants, etc.) from specific labeling or licensing requirements.
M	Good Manufacturing Practices (GMP) and requirements for factory premises, materials, equipment, and records.
M(I)	GMP requirements for the manufacture of homeopathic medicines.
M(II)	GMP requirements for cosmetics manufacturing.
N	List of minimum equipment required for the efficient running of a pharmacy.
O	Standards and limits for disinfectant fluids (phenolic type).
P	Life period or expiry date of drugs.
Q	List of coal tar colors permitted for use in cosmetics.
R	Standards for hair dyes containing coal tar colors.
R(I)	Standards for toothpastes and tooth powders.
S	Standards for cosmetics as per the Bureau of Indian Standards (BIS).
T	Requirements for manufacturing premises and GMP for Ayurvedic, Siddha, and Unani drugs.
U	Particulars to be displayed on the label of Ayurvedic, Siddha, and Unani medicines.
V	Standards for Ayurvedic, Siddha, and Unani drugs.
W	List of drugs whose import is prohibited.
X	List of narcotic and psychotropic substances to be sold only on special prescription forms and maintained in special registers.
Y	Requirements and guidelines for clinical trials and import/manufacture of new drugs.
Z	Post-marketing surveillance requirements for new drugs.
Z1	Pharmacovigilance requirements for new drugs and biologicals.