New Delhi: To check the indiscriminate use of antibiotics, anti-tuberculosis and some other drugs in the country, the union health ministry has notified amendments to the Drugs and Cosmetics Act, 1940 under which a new provision Schedule H1 has been included to curb over the counter (OTC) sale of certain antibiotics and anti-tuberculosis drugs from March 1, 2014.
Forty-six drugs, comprising mainly third and fourth generation antibiotics, have been placed under this restricted category and the sale of these drugs could only be done on furnishing an appropriate prescription letter of a doctor. Also, the seller has to retain a copy of the prescription letter and maintain a separate register that records the name of the buyer and the doctor who prescribed the medicine along with other necessary details.
To spread awareness, a mandatory warning has to be printed in a red box on the label of listed drugs and any violation of the new rule can result in prosecution, states the notification, which was issued on August 30.
Dr Madhukar Pai, associate professor at McGill University and associate director, McGill International TB Centre, in an exclusive conversation with India Medical Times said, “This Government of India order and the Chennai Declaration are important to raise awareness about the rampant abuse of antibiotics, including anti-TB drugs, in India, especially over the counter use.”
On the question whether the notification would instil a sense of confidence among international medical community about India’s seriousness to tackle the global challenge of antimicrobial resistance Dr Pai said, “I am not sure if the order alone will increase the confidence of the international medical community. The big concern for me is how the government will actually implement and enforce the order. Weak enforcement will mean that it will be business as usual and nothing will actually change on the ground. Only strict enforcement of the order will help show that India is serious about curbing antibiotic abuse.”
Regulating over the counter sale of antibiotics was one of the key recommendations of the Chennai Declaration, besides the need for monitoring antibiotics usage in hospitals, stepping up infection control, regulation of antibiotics in veterinary practice, setting up a National Antibiotic Resistance Monitoring Network, and facilitating clinical research for preventive strategies.
Dr Abdul Ghafur, coordinator, Chennai Declaration and a consultant in infectious diseases and clinical microbiology at Apollo Specialty Hospital, Chennai told India Medical Times, “The new amendment would certainly reduce indiscriminate buying of over the counter antibiotics for simple problems to tuberculosis. First of all, most prescriptions for the drugs are unnecessary, they are increasing the number of infections that become resistant to antibiotics. Moreover, people don’t complete the course and hence the numbers of antimicrobial resistance are increasing. There is a public health threat from infections that are resistant to multiple antibiotics and there is an urgent need to develop new treatments, which is one of the major issues raised in Chennai Declaration.”
He said, “This is one of the boldest steps taken by the Ministry of Health and Family Welfare and I have worked with them on the same issue for one and a half year. Undoubtedly, the Chennai Declaration speeded up the process. This is just a start as bringing many drugs under the net at the same time was not feasible. We are expecting that more drugs would be listed in this category where prescription by the doctor would be a prerequisite.”
Dr A Muruganathan, president, Association of Physicians of India, told IMT, “Personally, I believe it should not be only about certain antibiotics and anti-TB drugs for which a prescription letter should be mandatory. No drug in India should be sold without a doctor’s advice. Also, the seller should ask for fresh prescription letter if there is a gap between the patient buying over the counter medicine and the date on which the doctor recommended. Like in other countries, India should take sincere steps to stop the practice of over the counter sale of antibiotics as it leads to growing antimicrobial resistance.”
“As we insisted in the Chennai Declaration, there should be proper training of young medical professionals on the proper use of antibiotics. It is also important to ensure that the present rule is implemented in full, as there would be initial hiccups especially in rural areas. More drugs could be added to the list in a phased manner. Regulation and monitoring should be ensured for antibiotic usage by the Central Drugs Standard Control Organisation,” he said.
Antibiotic resistance, one of the major health epidemics, is a global concern but the problem is particularly pressing in a developing country like India, where the burden of infectious diseases is high and healthcare spending is low. The present step taken by the government is welcome but it’s only the first move towards a plethora of challenges facing the unregulated practices in the country. More of such initiatives are required in immediate future.
by Vidhi Rathee