Tripped up by legal tangles
Two months ago, officials from the Food and Drug Administration (FDA) paid several visits to Dr Amit Joshi’s (name changed) nursing home in the western suburbs.
The FDA had just begun its crackdown on chemists, clinics and nursing homes to check whether these establishments were maintaining proper records for sale of medicines, especially abortion pills, and for procedures such as sonography.After Dr Joshi showed the officials records for abortion medicines, the officials asked for records of all medicines stocked in the hospital. He could not produce the procurement bills because the medicines had been replaced by patients who used them, over time.
“When a patient comes to a nursing home and seeks treatment, the hospital provides medicines. When the patient gets discharged, he is asked to replace the medicines. We do not have a pharmacy and are not allowed to stock a lot of medicines. Replacement is the most logical practice, but then we cannot keep records for every medicine,” said Dr Joshi.
The FDA has brought this practice of replacement medicines — where patients are asked to replace medicines used by them during hospitalisation — under the scanner. According to the Drugs and Cosmetics Act, nursing homes are allowed to keep only life-saving medicines, to be used during emergencies.
They are also not allowed to sell medicines, because they do not have a pharmacist’s license, unlike big hospitals. They are only allowed to use those medicines as part of treatment, but are required to keep extensive records of both procurement and dispensing of these drugs.
“We keep stock for three to four patients. Many medicines come in vials, which get used for more than one patient. It would be wasted if each patient gets one separately. Also, one cannot ask patients to get medicines before the treatment, then doctors may call for a gamut of drugs, which again would be wasted and costs would go up for the patients,” said Dr Shivkumar Utture, financial secretary, Indian Medical Association, who has a nursing home in Matunga.Doctors said that there is no clarity on whether the practice is illegal. "We have to follow the law. But insisting on something that was not implemented for several years is not fair. We need some guidelines from the FDA. Also, I believe the choice must be given to patients when it comes to paying for medicines or replacing them," said Dr Bipin Pandit, executive council member, Maharashtra Medical Council (MMC).
“As per the law, nursing homes are allowed to dispense medicines, but not sell them. Isn’t that problematic?” he asked.
However, the FDA stance is that it is only implementing the law.
“The practice of replacement is potentially hazardous because not everyone checks the expiry date of the medicines or details of the manufacturers,” said Mahesh Zagade, state FDA commissioner.
“We are ready to help them if there is a genuine problem, but not following the law because it was not implemented earlier is not acceptable,” he said, adding that his officials would continue to take action according to the law.