The Nagpur bench of the Bombay high court has ruled that doctors cannot be penalized for selling medicines to their patients as long as they follow the 1945 Drug Regulations. This decision could have major implications for medical professionals throughout India.
The case that the court was hearing concerned Dr. Prashant Tiple, a psychiatrist from Chandrapur who became involved in legal trouble after giving medication to a patient without having the "requisite licence," according to the authorities.
After a sting operation using a dummy patient, the Food and Drug Administration (FDA) filed a complaint against him under the Drugs and Cosmetics Act of 1940. Through counsel Mohit Khajanchi, he contested the charge.
Citing Rule 123 of the Drug Rules of 1945, the HC panel of justice Govinda Sanap dismissed the criminal case against the doctor. According to the court's interpretation of this rule, medical professionals are permitted to give medications to their patients without obtaining a separate pharmacy licence as long as they closely follow the Drug Rules of 1945.
The sessions judge was criticized by Justice Sanap for summoning the petitioner without giving specific reasons. The HC found that the judge's merely written order to "Issue notice to accused" was inadequate. Justice Sanap drew focus on the fact that the sessions judge's one-line order lacked the required application of mind and was therefore legally invalid. “Criminal prosecution is a serious matter. The court has to be very careful while passing such an order. Such an order, as and when challenged, has to be examined on the touchstone of law,” he added.
“The judge was required to examine the complaint and, on being prima facie satisfied with the disclosure of the offence by recording reasons, he was required to issue process. He, however, took cognisance without recording the reasons,” justice Sanap explained.
“The petitioner’s case would squarely fall within Rule 123 of Drug Rules of 1945,” justice Sanap stated in his ruling. “There is no evidence to show that he was selling the drugs from the counter to patients or to the public. It is not the case of the prosecution that he is running a pharmacy shop without any licence,” he concluded.
Doctors all around India who regularly prescribe drugs as part of their practice should find clarity and reassurance in this decision. It also emphasizes how crucial it is to keep accurate records and follow the regulations outlined in the Drug Rules.
(Input from various sources)
(Rehash/Priyanka Pandey)