Context
- The Union Ministry of Health and Family Welfare has amended the Drugs and Cosmetics Rules, 1945 to regulate the production and sale of medicinal products containing alcohol. The amendment seeks to prevent the misuse of medicines with high alcohol content and strengthen quality control mechanisms.
Why was the amendment introduced?
- The government observed that certain medicinal products containing ethyl alcohol were being misused as intoxicants.
- Some of these formulations contain high concentrations of ethyl alcohol, in certain cases up to 80–90% v/v, making them susceptible to misuse for intoxication.
- The amendment aims to:
- Prevent diversion of medicinal products for non-medical use.
- Ensure better regulation of alcohol-containing medicines.
- Strengthen monitoring and record-keeping mechanisms.
Key Amendments
- Formulations containing more than 12% v/v ethyl alcohol in quantities exceeding 30 mL will no longer be exempt under Schedule K and must obtain licences under the Drugs and Cosmetics Act, 1940.
- These products have been included under Schedule H1 of the Drugs Rules, making them subject to stricter prescription and regulatory requirements.
- Manufacturers and sellers must maintain detailed records of production, distribution, sales, prescriptions, and inventory.
The Main Schedules for Medical Drugs Include
- Schedule H: Prescription drugs that can be sold only on the prescription of a registered medical practitioner.
- Schedule H1: Drugs subject to stricter regulation and record-keeping requirements due to the risk of misuse.
- Schedule X: Narcotic and psychotropic substances requiring stringent control and special storage records.
- Schedule K: Drugs exempted from certain provisions relating to manufacture, sale, and distribution under specified conditions.
- Schedule G: Drugs that must carry the warning: “Caution: It is dangerous to take this preparation except under medical supervision.”
- Schedule C and C1: Biological and special products, such as vaccines, sera, and blood products.
- Schedule M: Prescribes Good Manufacturing Practices (GMP) and requirements for pharmaceutical manufacturing units.
| About the Drugs and Cosmetics Act, 1940 It regulates the import, manufacture, and distribution of drugs and cosmetics in India and ensures their safety, efficacy, and quality. Administered by the Ministry of Health and Family Welfare, the Act is enforced by the Central Drugs Standard Control Organisation (CDSCO) and State Drug Authorities. It lays down standards for drugs, cosmetics, medical devices, and clinical trials. |
With reference to the pharmaceutical regulatory framework in India and recent amendments to the Drugs Rules, 1945, consider the following statements:
1. Under Schedule K of the Drugs Rules, 1945, certain medicinal products are granted exemptions from regular licensing requirements under specific conditions.
2. Placing a medicinal formulation under Schedule H1 legally permits its over-the-counter (OTC) sale without a physician's prescription, provided a trace register is maintained.
3. The statutory threshold for mandatory licensing of ethyl alcohol-containing medicinal formulations applies exclusively if the alcohol concentration touches 100% v/v.
Which of the statements given above is/are correct?
(a) 1 only
(b) 1 and 2 only
(c) 2 and 3 only
(d) 1, 2 and 3
Correct Answer: (a) 1 only
Statement-wise Explanation:
• Statement 1 is correct: Schedule K explicitly contains provisions and lists of specific drugs/formulations that are exempted from certain licensing and operational parameters outlined in Chapter IV of the Drugs and Cosmetics Act.
• Statement 2 is incorrect: Shifting a medicine to Schedule H1 strictly prohibits over-the-counter (OTC) sales. It mandates that the formulation can only be sold against a valid prescription from a Registered Medical Practitioner alongside stricter logbook maintenance.
• Statement 3 is incorrect: The statutory threshold mandated by the government for removing the exemption is an ethyl alcohol concentration of more than 12% v/v in quantities exceeding 30 mL, not 100% v/v.