New Delhi: The dispute over Clause–5 of Schedule-K of the Drugs and Cosmetics Rules has once again taken a centre stage after Dr P Kamalasanan, a private medical practitioner from Kollam in Kerala was punished last month for dispensing drugs without a license.
Additional Sessions Judge, Kollam on August 7 sentenced Dr Kamalasanan of one-day “imprisonment” and also fined him Rs 1.20 lakh on the charges of running a pharmacy without a license from his clinic. Appearing before the court, Dr Kamalasanan reportedly served the sentence by remaining there till the rising of the court.
At the time of inspection by the state drugs control department, Dr Kamalasanan was reported to have found practicing along with his wife at his single-doctor clinic, Nava Bharat Hospital at Sasthamkotta, Kollam.
The verdict has yet again underscored the need to have clarity over the clause between the state drugs control department and private hospitals, which are fighting under an umbrella association called Qualified Private Medical Practitioners Association (QPMPA), Kerala.
While the association is of the view that the clause exempts a private medical practitioner to obtain a license for dispensing drugs to patients, the state drugs control department stands to its interpretation that only a single-doctor clinic can keep medicines and dispense them to patients, but he cannot open a separate pharmacy in his premises or sell drugs across the counter, for which it would be mandatory for him to obtain a license under the rules.
The Kerala chapter of Indian Medical Association (IMA) also stands by the interpretation of the state drugs control department.
Dr R V Asokan, chairman, Hospital Board, IMA Kerala, told India Medical Times, “Under the rules, only a single-doctor clinic is exempted from the process of obtaining a license before dispensing drugs and any clinic run with the help of more than one doctor falls under the category of hospital, for which it is mandatory to obtain a license to dispense medicines.”
QPMPA, however, doesn’t agree with this interpretation.
Dr Kishore Kumar, national secretary, QPMPA, told India Medical Times, “The Drugs & Cosmetics Act, 1940 & Rules, 1945 is extremely clear in every sense. The lack of clarity is with the drugs department which badly needs an entry into private clinics. The judiciary has more faith in the government, bureaucrats and the Indian Medical Association (IMA) leaders than in the rule books.”
He further said, “Dr Kamalasanan is a victim of misinterpretation of the Drugs Act, 1940. The Drugs Act is very clear that private clinics, the place where professional activities of registered medical practitioners take place, are exempted from the drug licence. Private clinics are fully protected from harassment of drug controllers.”
“The judge punished Dr Kamalasanan, who has 40 years of experience in running his clinic for not committing any crime! The court believed the drug officials who argued that Dr Kamalasanan’s wife, also a registered medical practitioner, was with him in the clinic and it was a crime. Would Dr Kamalasanan have been innocent if he was alone?” Dr Kishore Kumar asked.
Dr Asokan said, “The matter was dragged for several years when ultimately the Kerala High Court in 2010 clarified in a judgement that every hospital has to take a licence whether it is run by a medical or non-medical person. Though, under the Drugs and Cosmetic Rules, a doctor has a privilege to dispense drugs at his disposal without the need of a license, the difference here is quite clear. A clinic run by single doctor is different from a hospital where more than one doctor or consultants visit.”
“IMA Kerala is of the view that the privilege of the rules didn’t extend to the punished doctor (Dr Kamalasanan) as he was running a small hospital. Our private hospital board requests every hospital to obtain necessary license,” added Dr Asokan.
Dr M C Gupta, a medico-legal expert based in New Delhi, told India Medical Times, “The order given by the (Kollam) court is in positive direction. While the clause (Clause–5 of Schedule-K of the Drugs and Cosmetics Rules) allows a single doctor to stock, prescribe or dispense medicines without having a license, it does mandate a clinic run by more than one doctor to obtain a license.”
Reports quoting sources at the drugs control department mention that a doctor cannot dispense medicines on the prescription given by another doctor, neither can a visiting doctor dispense medicines from that clinic. In case a doctor couple practices together and found dispensing drugs to the patient from the same counter without a license, they shall also be liable to punishment, as happened in the case of Dr P Kamalasanan.
Dr Neeraj Nagpal, convenor of Chandigarh-based Medicos Legal Action Group (MLAG) and former president of IMA Chandigarh, told India Medical Times, “The Drugs and Cosmetic Rules are interpreted differently by different experts. Personally, I feel it was wrong to punish the doctor. It is totally arbitrary and unjustified to target doctors over a clause that clearly exempts the need to have a license to stock and dispense medicines for patients.”
He further said, “If we interpret the law by the viewpoint of the drugs control department then over two lakh medical practitioners should be behind the bars. Then why only few doctors are targeted and punished? They are merely being harassed by the inspection teams. Moreover, nowhere the law states that a doctor and his wife cannot dispense medicines working in separate rooms of the same clinic. I don’t see it illegal.”
“In a similar case, a doctor from Gurdaspur in Punjab has been sent notice to dispense medicine without license. We are waiting to see the developments and shall approach the court, if need arises,” Dr Nagpal added.
While the medical fraternity remains divided on the interpretation of the rules by the judiciary and the drugs control department, an early clarification from lawmakers will help lakhs of medical practitioners to avoid legal battles with the law enforcing agencies.
According to Dr R V Asokan, the Govt of Kerala has extended the privilege to dispense drugs without a license given to a single doctor to a doctor couple as well.
by Vidhi Rathee
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