Doctors Cannot be Prosecuted for Dispensing Medicines: Bombay HC

Nagpur: In a significant ruling, the Nagpur bench of Bombay High Court has observed that doctors cannot be prosecuted for dispensing medicines to their patients if they adhere to the Drug Rules of 1945.

This observation was made by the HC bench comprising Justice Govinda Sanap while considering a plea by a Chndrapur-based Psychiatrist, who found was facing criminal proceedings for selling medicines to a patient.

While the authorities found him guilty for dispensing drugs without a valid licence, the Bombay High Court bench noted, "He is ... authorized by virtue of this exemption to supply the medicines to his patients."

The doctor was facing criminal proceedings dated 02.08.2022 filed for the Commission of an offence under Section 18(c) punishable under Section 27(b) (ii) of the Drugs and Cosmetics Act, 1940.

After receiving information that the doctor was selling medicines to the patients, a dummy patient was sent to the Psychiatrist's clinic and he examined the patient, prescribed some medicines, and provided/sold him the medicines available with him under the bill. Following this, the drug inspector filed the complaint against the doctor.

The authorities claimed that stock of sale of medicines by the doctor to the patient was in contravention of provisions of Section 18(c) of the 1940 Act. However, the doctor argued that he was a registered medical practitioner and Section 18(c) was a part of the Chapter IV of the Act of 1940.

As per Drug Rules, 1945, more particularly Rule 123, the drugs specified in Schedule K are exempted from the operation of Chapter IV of the Act of 1940, argued the doctor. It was further contended that the Psychiatrist's case was governed by Schedule K, Clause (5) read with Rule 123 of the Drugs Rules, 1945. 

The doctor argued that the entire stock was duly accounted for at the time of inspection itself and the report of the analyst showed that the drug was of standard quality and not a spurious drug. Therefore, the doctor contended that his case squarely fell under Rule 123 of Rules of 1945 read with Schedule K, clause 5.

Opposing this, the State contended that the drug was stocked for the purpose of sale and provisions of Rule 123 of the Rules of 1945 read with Schedule K, Clause 5 were not applicable in this case. It was argued that the doctor was not supposed to maintain the stock and sell drugs out of the stock to his patient.

The counsel for the doctor relied on the judgments in the case of Dr. Ritesh S/o. Nandkishor Dixit .v/s. State of Maharashtra, and S. Athilakshmi .v/s. State Rep. By the Drugs Inspector to argue that the applicant's case was covered under Rule 123 read with Schedule K and therefore, the prosecution lodged against him was without any basis.

In these decisions, it was held that the exemption provided by Rule 123 is to the registered medical practitioner. If the drug is provided by the medical practitioner, which is exempted under Rule 123 read with Schedule K, then the offence under Section 18(c) of the Act of 1940 would not get attracted.

While considering the matter, the HC bench noted that the applicant was a registered medical practitioner, a psychiatrist. The drug inspector had sent a dummy patient to the applicant to confirm the information that he was selling drugs to the patients without licence. Further, the court noted that the prescription issued by the doctor to the dummy patient was part of the record and the medicine prescribed was provided by the doctor to the patient under the bill.

The inspector, after the raid, called upon the applicant to produce the documents to account for the stock of medicines maintained by him. The applicant produced the necessary bills for the purchase of medicine from Suganchand Medical Stores.

"It is not the case of the respondent that this purchase of a medicine was illegal or unauthorized. It is also not the case of respondent that Suganchand Medical Stores had no authority to maintain the stock and sell the medicine. The only allegation is that, being a registered medical practitioner, he was not supposed to provide or sell the medicines to the patient," noted the HC bench.

"Learned APP conceded that under the Act and the Rules there is no provision which provides for maintaining a particular quantity of a drug by the registered medical practitioner. In other words, it is not the case of the respondent that the quantity of the drug maintained was beyond the permissible limit. It is undisputed that the entire stock of medicines found with the applicant was duly accounted for. It is not the case of the respondent that, out of this stock, a particular quantity was sold or provided without maintaining the record," it further observed.

The court observed that "It is not the case of the respondent that he was running a pharmacy shop without any licence. It is not their case that he was selling the medicine from the counter to patients or to the public."

Therefore, considering these facts, the HC bench deemed it necessary to examine whether the applicant's case fell within the exemption provided under Rule 123 read with Schedule K of the Rules of 1945.

Perusing Section 27(b)(ii) of the 1940 Act the Court noted that in a case of contravention of Section 18(c), a sentence of imprisonment not less than three years and extending up to five years has been provided. Similarly, for contravention of Section 18(b) of the Act of 1940, a sentence up to one year alongwith a fine has been provided.

Further, the Court took note of the fact that Rule 123 of the Rules of 1945 specifically provides for exemption from the application of provisions of Chapter IV of the Act of 1940. Schedule K, Clause 5 exempts the application of Chapter IV of the Act of 1940 to the drugs supplied by registered medical practitioner to his own patient.

Noting that the doctor duly examined the dummy patient, diagnosed his ailment and accordingly prescribed the medicines, the Court opined that

 "the case of the applicant would squarely fall within Rule 123 of the Rules of 1945 and Schedule K, clause 5. The stock with him was duly accounted for. 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 license. He is, therefore, authorized by virtue of this exemption to supply the medicines to his patients. In my view, therefore, Rule 123 of the Rules of 1945 and Schedule K, clause 5 would be squarely applicable to the case of the applicant. On the basis of the averments made in the complaint, it is not possible to conclude that the provisions of Rule 123 of the Rules of 1945 and Schedule K, clause 5 are not applicable to the case of the applicant," observed the Court.

Addressing the argument of the prosecution that the doctor did not maintain the register of the stock and the supply of the medicines to his patients, the Court noted, "I have already stated that it is not the case of the respondent that, out of this stock, any medicine was sold or supplied by him to his patient and it was not accounted for. The only evidence placed on record is the bill of supply of a medicine to the patients. In my view, therefore, this submission also cannot be accepted."

The HC bench further criticised the Sessions judge for issuing summons/process without recording reasons. In this regard, the HC bench observed, "Learned 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. Learned Special Judge has taken cognizance without recording the reasons."

"Perusal of the order would show that this one line order passed by the learned Additional Sessions Judge clearly shows that it is bad in law inasmuch as it does not reflect the application of mind. Learned Judge, as can be seen from this order, has not recorded any reason for issuing the process against the accused. The 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 touch stone of the law," it further observed at this outset.

Further, the Court referred to the Supreme Court order in the case of Lalankumar Singh and others v's State of Maharashtra, where the Apex Court held that the Court may not be required to record the detailed reasons, but the reasons recorded must be sufficient to indicate the application of mind by the Court before passing the order.

Finally, granting relief to the applicant doctor, the HC bench quashed the criminal proceedings against him and ordered, "On consideration of the entire material placed on record as well as the cryptic order passed by the learned Special Judge I am of the view that this prosecution against this applicant is not sustainable."

To view the order, click on the link below:

https://medicaldialogues.in/pdf_upload/bombay-hc-nagpur-bench-246759.pdf

Also Read: SC Grants Relief to Doctor for Storing Small Quantity Medicines without Licence, Says Does Not Endanger Public Interest