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Regulators have key role to address the menace of AMR: Dr SC Mandal

Peethaambaran Kunnathoor, Chennai
Monday, February 12, 2024, 08:00 Hrs  [IST]

Considering the rising threat of antimicrobial resistance (AMR), the drug regulators have to play a vital role in addressing the menace, impact of which is round the world at present and the reason is due to misuse, overuse and underuse of the antibiotics, says Dr. Subhash C Mandal, chairman of the Regulatory Affairs Division of the Indian Pharmaceutical Association (IPA).
As a first step, the regulators should implement the Schedule H and H1of the Drugs and Cosmetics Rules properly and stop Over the Counter sale of antibiotics.
The pharmacists in the community and hospital pharmacies must ensure that they sell H and H1 antibiotics only on prescriptions by a qualified doctor, says Dr. Mandal.
He said there are some irrational prescriptions by certain doctors who prescribe antibiotics excessively and needlessly. The National Medical Commission has issued circulars against this tendency of the doctors several times, but it is not followed by all. Dispensing without pharmacists and selling without prescriptions need to be urgently stopped as part of curbing the AMR threat.
Dr Mandal was responding to some stories on AMR and NSQs appeared in Pharmabiz recently and commented that for the first time in the history of the health department in India, the Director General of Health Services (DGHS) under the Government of India issued one circular to the drug dispensing pharmacists in the country on January 1 this year appealing them to be vigilant of the antimicrobial resistance due to over or under use of the antibiotics. The DGHS wanted the pharmacists in the country to dispense antibiotics only on prescriptions.
As the custodian of the healthcare services in the country, the DGHS obviously wanted the pharmacists to be cautious on their part as healthcare service persons to curb the development of AMR which is becoming a global public health threat nowadays. According to Dr. Mandal, the regulatory division of the IPA is planning to associate with the government in all its activities and policy matters to prevent the antimicrobial threat which is mainly caused by the development of drug resistant pathogens. He said both the doctors and the pharmacists have important roles in bringing down the development of the antimicrobials.
Quoting Dr. Atul Goel, the DGHS, Dr. Mandal said prudent antibiotic use is the only option to delay the development of the resistance. “There are a lot of policies and regulations initiated by the government to address the menace of the AMR, but nothing of them is implemented properly. If the regulators desire to play their part strongly, they can easily stop 50 percent of the growth by implementing the D&C Rules. They should not allow dispensing H and H1 drugs without pharmacists and without prescriptions. This is the best time for the pharmacist community in the country to serve as a healthcare person in the crisis,” he said.
Talking to Pharmabiz, Dr Mandal, who was previously in the regulatory department of the West Bengal government said, the AMR is killing 1.27 million people worldwide and was associated with nearly 5 million deaths in 2019. Quoting the international medical journal Lancet, he said AMR will result in the global loss of 10 million lives per year by 2050. This reinforces one fact that use of antibiotics needs to be reduced and there should be a rational use and rational prescription for all antibiotics.


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