Is it illegal for a doctor-couple to dispense drugs without license?

Wednesday, September 24, 2014

by Vidhi Rathee

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.

Read the full judgement


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

Categories: FEATURES

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Comment by doctorc
2014-09-25 12:27:11

There is a very simple rule….. If an activity leads to financial gains for a doctor, it is illegal..

2014-09-25 16:28:15

Dear all, I think the grass root corruption starts when a huge sum is paid to get admission in Private Medical College, 60-70 lakhs plus annual fee of 8-9 lakhs, and that is not the end the PG seats are sold in advance. If a Doctor with MBBS degree in pocket after that much money paid or PG after paying hafty sum, the initial Ethics and Hippocrate oath by this framed doctor is lost. He and others with the same back -ground once they come to practice , they will break all the barriers , rules, ethics and start practising corruption as a tool to recover the money they spent. Many good students do not get medical seats because of reservation inspite of their good reults . if we really want to stop the corruption in medical practice , let us first make our efforts to convince the top govt to phase out and remove reservation over a period of 5 years and have all the 400 medical colleges to conduct a common fair entrance exam. The corruption will automatically come down to minimum as hard earned degree will remind the future doctors the value of ethics and fair medical practice.

Dept of Cardiac Surgery
Dept of Heart and Lung Transplant
Dept of MICS
Global Health City Chennai India

Comment by DeadDoc
2014-09-29 16:31:50

- It’s not illegal to set-up shops for “medicines” that have no proven efficacy.
- It’s not illegal to practice systems of care that are deemed to be pseudoscience.
- It’s practically not illegal (due to lack of enforcement) for medicine shops to “diagnose and dispense” medicines.
- It’s not illegal to sell tobacco and alcohol that have known deleterious effects on health.

But doctors selling medicines? Illegal! Wow!

Comment by Dr.B.Ravi Kumar
2014-10-18 07:02:43

Reservation is a very touchy issue.

Comment by Dr. A. K. Singh
2014-10-18 12:17:41

I agree with the comments of Dr. Kapadia that nowadays corruption starts in the beginning. Since most private medical colleges are owned by politically strong people, the law takes its own course – which, in our country, means never. If the Government and Civil Society is really intetested in being served by competent doctors, it has to take some unpleasant but necessary steps. Exams are the most obvious. So let us have one pan India Entrance Exam, one pan India exit exam (which will double, along with interviews, as entrance exam for post graduate courses, & one exit exam for PG studies (which will double as entry for superspecialty entrance). Medical Colleges – private or public & including institutes will have the duty toteach and train. A 50% failure rate for 2 consecutive years will lead to 50% reduction in seats. Merge MCI & NABH. One Country One Examining Body.

It can be done. All that is needed is political will. Results will be tremendous.


Comment by Prof. Manoj Sharma
2014-10-18 19:49:27

What Dr. Kapadia has stated has been harped again and again by me , in due course inviting problems for me by gang of those criticised by me in purview of reservation policies.
The feed backs have cleared one thing all the Govts, Achhe Din or Bure Din Types cannot do away with reservation even though the argument of thousands of years of suppression sounds funny to all.
I reiterate my views on CMC Vellore Model that brings about the affirmative action for downtrodden and also solves the problem on manpower for rural health.
Still there is time, create District Medical Colleges along with Central School type of Institutions .Admit poorest of poor to enable them worth appearing in competitive exams like Christian convents do. Let them compete and shine out . Do away with reservation if you want quality health care.
Do away with capitation by introducing a common entrance test sans reservation quota. The justice will be done to deserving and non deserving will be filtered out.
The corruption is not only due to the recovery of capitation fee but it is also due to recovery of thousands of years of suppression and injustice . The aim i certainly not the Hippocratic Oath it is hypocrisy attitude towards the facility provided by the Govt.

Comment by Prof. Manoj Sharma
2014-10-18 20:02:09

If MCI PG courses exams are merged with NBE(DNB ) courses exams. As many as 90 % of MCI PG course candidates will fail.
There are reasons that start from correction of answer sheets to prioritisation of sycophancy to HOD… followed by internal examiners and then with this help in next step approach to external examiners.
Fear is the key in facilitating clearance in the exam if the candidate is from reservation quota .. NO one wants to go to jail by failing them or rejecting their thesis. Many of the readers are aware of it and have experienced it too. My Dean of the medical college wanted to save me from the calamity so he used his powers to change the thesis supervisor of my reservation candidate who ruined a high profile thesis topic given to him. Despite university rules his thesis topic and guide were changed when there were hardly 8 months were left to submit his thesis. He got through in PG exams in first attempt without answering much. For him examiners were called that were not known to be strict and good examiners.
There is lot of talk going on against AYUSH and quacks and illegality in medical profession , above sited examples can be included in that

Comment by yogesh maini advocate
2015-05-07 17:05:20

totally agree with you but it is true that corrupt/malafide practice has been running with such a noble profession like doctors and also defaced the profession we have take strong effective and strong action regarding these if you have any break through just share with us

Zindgi Live Foundation

Yogesh Maini
ch. No.131 lawayer chamber,
Delhi High Court, New Delhi

Comment by GVG
2015-09-08 19:33:07

Clause 5 of Schedule K(Exemption of all provisions of Chapter 4 of the Act, subject to few conditions) made under Section 123 of Drugs and Cosmetics Act says “Drugs supplied by a registered medical practitioner to his own patient or any drug specified in Schedule C supplied by a registered medical practitioner at the request of another such practitioner if it is specially prepared with reference to the condition and for the use of an individual patient provided the registered medical practitioner is not (a) keeping an open shop or (b) selling across the counter or (c) engaged in the importation, manufacture, distribution or sale ofdrugs in India to a degree which render him liable to the provisions of Chapter IV of the Act and the rules thereunder.”
The subjected conditions are :
[(1)The drugs shall be purchased only from a dealer or a manufacturer licensed under these rules and records of such purchases showing the names and quantities of such drugs together with their batch numbers and the names and addresses of the manufacturers shall be maintained. Such records shall be open to inspection by an Inspector appointed under the Act, who may, if necessary, make enquiries about purchases of the drugs and may also take samples for test.
(2) In the case of medicine containing a substance specified in 1[Schedule G, H or X] the following additional conditions shall be complied with]:
(a) the medicine shall be labelled with the name and address of the registered medical practitioner by whom it is supplied;
(b) if the medicine is for external application, it shall be labelled with the words “For external use only” or if it is for internal use with the dose;
(c) the name of the medicine or ingredients of the preparation and the quantities thereof, the dose prescribed, the name of the patient and the date of supply and the name of the person who gave the prescription shall be entered at the time of supply in register to be maintained for the purpose;
(d) the entry in the register shall be given a number and that number shall be entered on the label of the container;
(e) the register and the prescription, if any, on which the medicines are issued shall be preserved for not less than two years from the date of the last entry in the register or the date of the prescription, as the case may be.
[(3)The drug will be stored under proper storage conditions as directed on the label.]

Comment by dr j nair
2016-07-22 18:14:36

is there any limit to stock drugs for a rmp?

Comment by pkoteswararao
2017-01-07 08:26:51

Really we can treat at lowest cost with best medicines.because primary health problems are cure verysoon. But the Doctors are using high Mrp drugs and higher antibiotics in primary stages also.so Rmp doctor also following them.

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