The Maharashtra Food & Drugs Administration (FDA) will begin an inspection campaign on August 1st in an effort to reduce the abuse of Schedule-K medications.
This campaign will focus on private doctors who may have broken laws related to supplying medications to non patients and maintaining inaccurate records.
The FDA declared in a July 16 circular that the inspection drive will start in 15 days. Every day, drug officers are expected to check ten or more doctors.
Since the Drugs and Cosmetics Act of 1945 does not directly address these issues, there is a great deal of uncertainty among doctors over the parameters of inspection.
We will gather information through our sources and investigate private doctors suspected of violations. To be clear, not all doctors will be randomly inspected.
D R Gahane, Joint Commissioner of FDA Maharashtra
Gahane acknowledged the complexity surrounding drug stockpiling but pointed out that inspections will concentrate on two key parameters.
“Firstly, while the act doesn’t specify drug quantities, it requires maintaining records of distribution and procurement. Secondly, doctors can only provide medicines to their own patients; selling to non-patients could make them unauthorized pharmacists. We will examine these aspects,” he said.
The announcement follows a complaint filed to the FDA and the Ministry of FDA by the Maharashtra State Chemists and Druggists (MSCDA), an apex body comprising almost 10,000 chemists and druggists, over the alleged rampant misuse of Schedule-K by hospitals, doctors, bogus physicians, and homoeopathic doctors.
The letter dated June 24, stated, “Many cases of misuse of this provision have been unearthed by the regulators in the state. Doctors are running medical stores on their premises. They stock huge quantities of medicines and sell them to their patients as well as outdoor patients. This is being done without a license and without pharmacist services.”
The letter from MSCDA secretary Anil Navandar continued, “…it is seen that these provisions are grossly violated, they are not keeping mandatory records, and they are selling medicines without bills and evading many taxes like GST. Even a few doctors sell free physician samples.”
Drug resistance can result from unskilled doctors prescribing antibiotics excessively, based on complaints made by pharmacists, according to Jagannath Sakharam Shinde, chairman of the MSCDA.
“Every time we address the issue of growing drug resistance with the government, they blame the chemists. However, many unqualified individuals are randomly prescribing or selling such medicines without licenses,” he said.
The president of the All India Organization of Chemists and Druggists (AIOCD), Shinde, has also written to the country's drug controller general, Dr. Rajeev Singh Raghuvanshiji.
Another section, however, asserted that the new FDA effort would inadvertently impact susceptible patients and worsen the problem of harassment directed towards doctors.
This campaign could adversely impact many needy patients. The fear of penalties might prevent patients from receiving medications at reasonable rates, and there’s a risk of increased harassment and intimidation of doctors. More critical attention is needed on the illegal sale of medications without prescriptions, which remains a significant concern in many drugstores.
Abhay Pandey, President of the All Food and Drugs License Holders Association
(Input from various sources)
(Rehash/Priyanka Pandey/MSM)
