'Higher Relief' to Doctors from the scanner of FDA on the alleged grounds of selling of medicines. - Adv. Rohit Erande. ©

 'Higher  Relief' to Doctors from the scanner of FDA on the alleged grounds of selling of medicines.

Adv. Rohit Erande. ©

IN THE HIGH COURT OF JUDICATURE AT BOMBAY NAGPUR BENCH, NAGPUR.

Case Details : CRIMINAL APPL ICATION (APL) NO. 638 OF 2023

Dr. Prashant S/o. Gokul Tipale V/s. State of Maharashtra.

CORAM : G. A. SANAP, J., Decided on 22^nd July 2024.

Following a complaint from the Chemists Association, the Food and Drug Administration (FDA) has reportedly started  a state-wide drive to inspect private doctors in Maharashtra stocking drugs in large quantities and selling them to patients. This action has stirrd up the hornet’s nest and the Doctors have been accusing the authorities for harassing them under the garb of inspection. On this background the recent judgment of Hon’ble Bombay High Court should provide solace to Doctors.

 

Facts in Short :

1. The original complaint was filed against the Petitioner – Applicant –a M.D. Psychiatrist himself,  by the drug inspector on the allegation that the drug inspector had received information that the applicant was indulging in a sale of medicine to the patient without any licence. Therefore, a dummy patient was sent to the clinic. The said patient was examined by the applicant. The applicant then prescribed the medicines and provided/sold him the medicines available with him under the bill in violation of Section 18(c) of the  Drugs and Cosmetics Act of 1940.

 

2. It was the case of the Applicant that  as per the 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 i.e. Sec.18 as produced herein below .

 

18. Prohibition of manufacture and sale of certain drugs and cosmetics.

a…

b….

(c) 3[manufacture for sale or for distribution, or sell, or stock or exhibit or offer for sale,] or distribute any drug 9[or cosmetic], except under, and in accordance with the conditions of, a licence issued for such purpose under this Chapter:

Provided that nothing in this section shall apply to the manufacture, subject to prescribed conditions, of small quantities of any drug for the purpose of examination, test or analysis :

Provided further that the 10[Central Government] may, after consultation with the Board, by notification in the Official Gazette, permit, subject to any conditions specified in the notification, the 11[manufacture for sale or for distribution, sale, stocking or exhibiting or offering for sale] or distribution of any drug or class of drugs not being of standard quality.

 

3. According to the applicant, the entire stock was duly accounted for at the time of the inspection itself. The report of the analyst shows that the drug was of standard quality. In other words it was not a spurious drug.

4. The applicant  applicant has relied upon the following two decisions to make good his submission that the case of the applicant is covered under Rule 123 read with Schedule K and therefore, the prosecution lodged against him was without any basis.

a. Dr. Ritesh S/o. Nandkishor Dixit .v/s. State of Maharashtra, Criminal Application No. 139 of 2021, decided on 15.07.2021

b. S. Athilakshmi .v/s. State Rep. By the Drugs Inspector, reported in 2023 SCC OnLine SC 269 ::: Uploaded on - 03/08/2024 (Judgment of hon’ble Supreme Court).

In this Court, Honble Apex Court held that “When a small quantity of medicine has been found in the premises of a registered medical practitioner, it would not amount to selling their medicines across the counter in an open shop”

Link for the Article on this case https://advrohiterande.blogspot.com/2023/03/supreme-relief-to-senior-lady-doctor.html

 

 

5. In these decisions it is 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 will not get attracted.

 

Held ;

After hearing of both the parties, his Lordship was pleased to quash the order of issue notice against the Applicant and observed :

 

a. IT appears from the record that the dummy patient was examined by the applicant. The prescription is part of the record. The medicine prescribed was provided by the doctor to the patient under the bill.

b. The applicant produced the necessary bills for the purchase of medicine from the Suganchand Medical Stores. It is not the case of the respondent that this purchase of a medicine was illegal or unauthorized nor it is the case  that the Medical Store had no license to sell the medicines.

c. The Court further observed that the Govt. pleader also 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.

d. 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 and thus the Court held that the Applicant -Doctor is, therefore, authorized by virtue of this exemption to supply the medicines to his patients.

e. The Court also rejected the contention of the Govt. that the register of the stock and the supply of the medicines to his patients was not maintained as 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.

f. The Hon’ble Court was also not pleased with the modus of the Trial judge of passing the one line order “issue notice to accused” without assigning any reasons. It was observed that the criminal prosecution is a serious matter. The Court has to be very careful while passing such an order. The Court held that the impugned order being passed mechanically without application of mind cannot be sustained.

 

This case is indeed a solace to Doctors who are doing the practice as per rules. Cardinal principle of Law says “If a particular thing is required to be done in a particular way, then such thing should be done in that manner else should not be done at all”. I think this principle was not followed by the authorities in this case.

 

Regds

 Adv. Rohit Erande. ©