Amendments to the Drugs and Cosmetics Act, 1940
The Union Health and Family Welfare Ministry has recently notified certain amendments to the Drugs and Cosmetics Act, 1940. As a result of these, antibiotics and anti-tuberculosis drugs will not be sold over the counter from March 1, 2014.
The Government’s move is expected to check the indiscriminate use of antibiotics, anti-TB and some other drugs in the country. The packaging of these drugs will have a mandatory warning printed with a red border on the label.
The Drugs and Cosmetics Act is an Act to regulate the import, manufacture, distribution and sale of drugs in India. It was passed by the Central Legislative Assembly and it received the assent of the Governor General on 10th April, 1940.
The main changes in Drugs and Cosmetics Act, 1940
The government has included a new provision, Schedule H1 to the Drugs and Cosmetics Act to check the indiscriminate use of antibiotics, anti-TB and some other drugs in the country. As many as 46 drugs have been placed under this restricted category which mainly comprises third and fourth generation antibiotics, anti-TB and some other drugs.
The following restrictions will be applicable.
- The packaging of these drugs will have mandatory warning printed on them in a box with a red border on the label and will be sold by chemists on production of a prescription.
- The chemist will retain a copy of the prescription and maintain a separate register for these 46 drugs where the name of the patient and the details of the doctor who prescribed the drugs will be noted. This register will have to be kept for three years before being destroyed.
- The Central Drugs Standard Control Organisation (CDSCO) has the responsibility to enforce the order.
- Violation of this provision can result in prosecution.
- State Drug Inspectors can conduct surprise inspections at the pharmacies and chemist shops to check the registers and sale of these 46 drugs under Schedule H1.
Why the recent changes?
Medical societies in India, for the first time, joined together and organised a remarkable symposium— A Roadmap to Tackle the Challenges of Antimicrobial Resistance —in Chennai on August 24, 2012, to discuss the problem of antimicrobial resistance and possible solutions that were applicable to the situation in India. International experts were also invited to explain how high-income countries are trying to tackle antimicrobial resistance.
The intention was to gain a broad consensus and range of opinions to guide formation of the road-map. The product of this meeting was the document “Chennai Declaration“.
Restricted sale of antibiotics was one of the main recommendations of the Chennai Declaration to check drug resistance which is emerging as a serious health issue in the country. Resistance to antibiotics and an increase in drug resistant TB cases are cited as a result of improper prescription and consumption of antibiotics which are easily available.
The Chennai Declaration recommends urgent measure to formulate an effective national policy to control the rising trend of antimicrobial resistance, including a ban on over-the-counter sale of antibiotics, and changes in the medical education curriculum to include training on antibiotic usage and infection control.
The latest amendments to the Drugs and Cosmetics Act are seen as step in the right direction to put an effective check on indiscriminate antibiotic usage in India. It is likely to go a long way in supporting India’s fight against growing drug-resistance in bacteria. It is one of the major challenges to India’s TB control programme.
About Schedule H and Schedule X drugs in India
Schedule H is a class of prescription drugs under the Drugs and Cosmetics rules introduced in 1945. These are drugs which cannot be purchased over the counter without the prescription of a qualified doctor. However, enforcement of Schedule H laws in India is lax, compared to the more restrictive Schedule X, for which a mandatory documentation trail must be maintained.
The list of Schedule X drugs includes over 536 drugs. The Schedule X drugs includes Narcotic and Psychotropic drugs which causes delusion, hallucination, psychosis, sedation and hypnosis.