Drug makers must comply with revised norms: Government
Context:
The Union Health Ministry has warned that pharmaceutical companies not following the revised Schedule M norms will have their licenses cancelled. The move comes after children in Madhya Pradesh and Rajasthan died from consuming a toxic cough syrup that contained diethylene glycol (DEG) — a poisonous chemical.
What is Schedule M?
It is part of the Drugs and Cosmetics Act, 1940.
It sets out Good Manufacturing Practices (GMP) for drug manufacturing in India.
The revised Schedule M (updated in 2023–24) strengthens these standards and aligns them with international GMP guidelines.
It requires:
Enhanced Pharmaceutical Quality Systems
Quality Risk Management
Upgraded infrastructure, such as computerised storage and equipment validation
All pharmaceutical companies must comply by December 31, 2025.
Trigger for stricter action:
Over 10 children died in Rajasthan and Madhya Pradesh after consuming Coldrif cough syrup.
Testing showed DEG contamination (beyond permissible limits).
DEG is a toxic chemical that can cause kidney failure and death when ingested.
The Tamil Nadu Drugs Control Department detected this contamination and recommended cancelling the manufacturing license of the company in Kancheepuram.
Criminal proceedings have also been initiated.
Government’s response:
The Health Ministry held an emergency meeting with state drug controllers.
It instructed all states to ensure:
Strict quality testing of cough syrups and other liquid formulations.
Immediate action against violators.
Promotion of rational use of cough syrups.
Schedules under the Drugs and Cosmetics Act, 1940
The Drugs and Cosmetics Act, 1940 and Rules, 1945 regulate the import, manufacture, distribution, and sale of drugs and cosmetics in India.
To ensure safety, efficacy, and quality, various “Schedules” are included under the Rules, each specifying standards, procedures, or restrictions related to drugs.
1. Schedule G – Prescription Warning Drugs
These drugs must carry a label warning: “Caution: It is dangerous to take this preparation except under medical supervision.”
Used for diseases requiring continuous medical monitoring.
Examples: Hormones, sulphonylureas, thyroid drugs.
2. Schedule H – Prescription Drugs
Can be sold only on prescription of a registered medical practitioner (RMP).
Dispensing must be done by a licensed pharmacist.
Label: “Rx – To be sold by retail on the prescription of a Registered Medical Practitioner only.”
Examples: Antibiotics, antipsychotics, anti-TB drugs.
3. Schedule H1 – Restricted Prescription Drugs
Introduced in 2013 to control antimicrobial resistance and drug abuse.
Sale requires recording of patient and doctor details (retained for 3 years).
Label: “Rx – Dangerous to take this preparation except in accordance with medical advice.”
Examples: Certain fluoroquinolones, third-generation cephalosporins, carbapenems, narcotic analgesics.
4. Schedule X – Controlled Drugs (High Potential for Abuse)
Covers narcotic and psychotropic substances with very high abuse potential.
Sale only on special prescription forms issued by authorized practitioners.
Stock and sale must be strictly recorded and audited.
Examples: Amphetamines, barbiturates, morphine, methadone.
5. Schedule K – Exemptions for Certain Drugs
Lists drugs exempted from certain provisions of the Act or Rules — e.g., licensing, labeling, or record-keeping — under specific conditions.
Mainly covers:
Veterinary drugs
Household remedies
Traditional medicines
Drugs supplied by government hospitals
6. Schedule M – Good Manufacturing Practices (GMP)
Lays down minimum manufacturing standards to ensure drug quality, safety, and efficacy.
Revised (2023–24): Now includes:
Pharmaceutical Quality System (PQS)
Quality Risk Management (QRM)
Equipment validation, computerized storage systems
Deadline for compliance: December 31, 2025
7. Other Key Schedules
Schedule | Covers |
Schedule C & C1 | Biological products like vaccines, sera, toxins, insulin. |
Schedule D | Classes of drugs exempted from import provisions. |
Schedule E1 | Lists poisonous substances under Ayurvedic, Siddha, Unani medicines. |
Schedule F | Standards for biological products (e.g., vaccines, sera). |
Schedule J | Diseases for which claims to cure are prohibited (e.g., cancer, diabetes). |
Schedule P | Shelf life of various drugs. |
Schedule P1 | Guidelines for life period of drugs. |
Schedule O | Disinfectant and antiseptic solutions. |
Schedule Y | Requirements and guidelines for clinical trials of new drugs. |
Inshort
Schedule | Purpose / Regulation Area |
G | Medical supervision warning drugs |
H | Prescription-only drugs |
H1 | Strictly controlled prescription drugs |
X | Narcotic / psychotropic drugs |
K | Exempted and veterinary drugs |
M | Good Manufacturing Practices (GMP) |
C, C1, D, E1, F, J, P, Y | Technical standards & specialized categories |