Drug Licence - Lack of clarity - Pharmabiz

Lack of clarity on Schedule K of D&C Rules creates confusion
between private hospitals & DC dept in Kerala

http://www.pharmabiz.com/NewsDetails.aspx?aid=83626&sid=1

Dear Mr. Peethaambaran Kunnathoor, Chennai

Sorry to say you are absolutely wrong. The Drugs & Cosmetics Act, 1940 & Rules, 1945 is extremely clear in every sense. The lack of clarity (or sense) is with the Drugs department which badly needs an entry into private hospitals and the judiciary which has more faith in the Govt. pleaders, bureaucrats & IMA leaders than in the rule books. A new path built to make “Outlaws” out of a “Law of the Land”! DC Kerala wants to keep all RMPs at his beck and call to dictate terms and conditions and market the products, they want. Many officers have drug manufacturing units or distribution firms and an entry into private hospitals is a tantalizing prospect.

The Act is in force for the last 74 years and no one else in India thinks it is not clear. A previous Drugs Controller in Kerala (the one with law degree) wanted to prove that DC officers in Kerala are smarter than their counterparts in other states. For him and his kind, the letter "a" in a sentence by virtue of the position it holds as ‘Numero Uno’ is used in place of “one" and is singular. It is not clear what that Drugs Controller understands when the priest says during marriage ceremony – “Though you have two bodies, as husband & wife, you are one." Anyhow, the DC Kerala found out that husband and wife will be considered “a single entity” and can be exempted from drug license. In fact, our Health Secretary better aware of Sec. 9 of IPC, 1860 & Sec. 13 of The General Clauses Act, 1897 permitted this formula to please IMA of Kerala to get a cut for every license issued!

The bureaucracy is convinced that "a registered medical practitioner" mentioned in Item 5 Schedule K of Drugs Act is "a single RMP" and if two or more RMPs join together under a (? one) roof their constitutional right will vanish. However, a husband and wife can enjoy that right, but not when their son joins them! The Drugs Act is very clear that private hospitals, the place where professional activities of RMP/RMPs take place, is exempted from Drug Licence. Private hospitals are fully protected from harassment of Drugs Controllers. The Govt. hospitals are exempted from Sec. 18 of the Drugs Act, 1940, if there is a pharmacist. To run a blood bank both (private/public) institutions must have a license. (Read Items 5, 5A & 5B in Sch. K together.)

The judge punished Dr. Kamalasanan, an RMP, who has 40 years of experience in running his hospital for not committing any crime! The Court believed the drug officials who argued that his wife, also an RMP, was with him in the hospital and it was a crime. Dr. Kamalasanan would have been innocent if he was alone! The DC has not said anything about an RMP having two wives. Will they permit a girl friend in place of a wife? Do they expect a marriage certificate/photo displayed prominently to prove things? The knee bending without any protest of doctors has increased the confidence of the DC, and we expect more progressive regulations like a (? One) couple should sleep only on a (? ONE) single bed. If they sleep in two beds, God help them! The saying – We get what we deserve – is no truer than today.

Doc imprisioned for sitting together with wife, a doc

The DC Officer, having charge for Kollam district (he can as well be called the Dist. Collector for Drugs) found the doctor is a criminal and charged him for running a pharmacy without licence under Secs. 18 & 27 of the Drugs Act. This can happen to all doctors even if they are running ‘one doctor’ hospitals. The trigger happy judge, for whom everything is pellucid, unlike his blindfolded counterparts, punished Dr. Kamalasanan, ignoring the arguments of a very senior advocate that the doctor has not violated any sections charged, as he is a registered medical practitioner who is exempted from Chapter IV of the Drugs Act. The judge could bring in charges not mentioned even by the DC. He is really Lord Siva with farsightedness!

The news appeared in the Times of India, Kochi ed. on 8.8.14 and no one in our noble profession bothered to raise even the little finger against this wrong judgment. And we have around 20 lakh registered medical practitioners, ignorant of their rights/dignity. There are hundreds of doctors’ associations all protecting the interest & welfare of their members. There is the MCI, also not bothered, while the Drugs department is forcing doctors to keep “open shop” and “sell across the counter” violating the Code of Ethics. MCI will have to rewrite their Code of Ethics to please the Drugs Department.

The judge never bothered to find out from the Dist. Collector of Drugs whether the charges against the doctor can be proved or not.  Dr. Kamalasanan is a victim of misinterpretation of the Drugs Act, 1940. Power makes vain people blind and irresponsible. They are blind to the damage to reputation of a practicing doctor brought about by courts or governments. “Our legal system has made life too easy for criminals and too difficult for law abiding citizens.” – Palkivala.

I request you to read the following sections & rules in the Drugs Act, 1940 & Rules, 1945 to see the truth and try to save the 20 lakh RMPs and their ignorant irresponsible leaders.

Sections: Preamble & S. 5; 7; 18; 18A; 18B; 21; 22; 23; 33; 33q; 33P & 34AA.

Rules: 1; 2. e, ea, ee, f, g & h; 33A; 49; 51; 58A; 59; 61; 62; 62A; 64; 65; 65 (5)(i), a, b, c, d & e; 65 (9); 65 (10); 65(11-A); 65 (15); 65 (18); 105; 123; Conditions of License in Form 20B; Schedule K – Items 5, 5A, 5B (together). 

Kindly keep in mind that the Drugs Act is not to control the use of drugs or its supply by the RMPs.

 Item 5 in Schedule K in the Drugs Rules have only one sentence ––

“Class of Drugs (exempted) –

Item 5. 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 of drugs in India to a degree which render him liable to the provisions of Chapter IV of the Act and the rules there under.”

The judiciary has already decided that “a registered medical practitioner” means “a single registered medical practitioner” and every RMP in India swallowed that, and so nobody can challenge it. ‘A’ is also used with the word “degree” and let us hope that will be “a single degree” or one degree. That means the open shop to be opened only “one degree” and selling across the counter also “one degree or say Re.1”!

For a layman, a plain reading of Item 5 in Schedule K cited, means – that a registered medical practitioner can supply drugs (to supply something one must purchase it as required, store it, arrange the drugs item-wise in a place called pharmacy in a hospital for easy dispensing and not in his consultation room as proposed by some officials) to his own patients and also to the patients of another RMP and that he can keep a closed shop (Right hand drive is not permitted in India and they never say left hand drive is permitted. Smoking in public is prohibited and they never say that it is permitted in private. Applying similar logic we can say that if an open shop is not permitted a closed shop is permitted – the lawmakers need not say that); can sell by being on the same side of the counter (that prohibited is selling across the counter), can import, manufacture, distribute and sell drugs up to a certain level/degree not violating provisions of Chapter IV of Drugs Act (speed up to 70 kms is not violation, but above that is violation).

The Law never imposes blanket prohibitions for anything.  There will be a loophole for all to escape. To achieve that, the presiding deity (Lord Siva - Siva linga) must be impressed and Parvathies are very expensive now-a-days. May God bless and save this Country.

If “a (? One) single RMP” is following all the above conditions meticulously, the RMP is exempted from Chapter IV of the Drugs Act and Sections 16 to 33A come under that Chapter IV. Dr. Kamalasanan, limpid, was punished under Sections 18 & 27 – One day imprisonment and a fine of Rs. 1.2 lakhs, just for the simple reason that the Judiciary in India at various levels of efficiency found out that “a registered medical practitioner” means “a single registered medical practitioner” and if two (husband & wife excluded because it is a mere “Kerala model”) or more sit together under one roof they must be punished. Who is ignorant of duties to the legislature? Yes, we can create Outlaws out of Laws and they (bureaucrats) want them badly!

QPMPA started this legal battle in 1991 and finally lost it in 2010. The ‘Parvathy’ entrusted to face Siva could not please ‘Siva’, we assume. The Review Petition No. 794/2010 was dismissed on 22.10.2010 and the eager Drugs Dept. fed up of the long wait, hounded private hospitals with a vengeance.  Dr. Kamalasanan was attacked on 9.11.2010 and punished on 7.8.2014. The hospitals of many QPMPA leaders were attacked with a vengeance.  Many cases are still in different courts. QPMPA leadership, decided to lie low – mainly due to lack of funds, indifference of members and sarcasm and scorn by leaders of sister associations.

However, QPMPA India is planning a “Curative Petition” before the Kerala High Court on this issue again and those interested/involved/harassed can join us and save the profession. The drafters of the Drugs Act, 1940 & Rules, 1945 are turning in their graves, and I can hear them always.

In that one sentence, two phrases are used – 1. “Keeping an open shop” & 2. “Selling across the counter”. If time permits kindly illuminate me on the meaning of these phrases –“open shop” & “selling across the counter”. This is from an Act of the Indian Parliament and how that can be applied on a medical practitioner! “Selling across the country” would have been a more sensible and suitable word or ‘selling over the counter’(OTC)! Judiciary will not accept the dictionary/encyclopaedias, but only context. Even then, what is “an open shop”? Is it one without walls/doors, or is it what we say that they ‘open shop’ at 8 am and ‘close shop’ at 8 pm, or is it one open 24 x 7 x 365? Search and kindly help all to be wiser! As an RMP, the accused is exempted from all the Sections in Chapter IV of the Drugs Act, 1940, and the pellucid Court has the minimal courtesy to inform a fellow professional, the gravity of the situation!

For a copy of Drugs Act, 1940 click – http://indianmedicine.nic.in/writereaddata/mainlinkFile/File222.pdf

Dr. K. Kishore Kumar, Ashoka Bhavan, Nr. MSM College, Kayamkulam 690502

M: 9447485532 Email - [email protected]

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