Protect Drugs & Pharmacy Acts of India — Press Release

Monday, 26 July 2010 19:23

A QPMPA Press Release — Drug Licence

By Dr. K. Kishore Kumar, State Secretary, QPMPA, residing at Ashoka Bhavan, Near MSM College, Kayamkulam 690502 for public information. Ph: Mob: 09447485532

QPMPA is a national organisation with more than 2500 registered modern medical practitioners as members in Kerala, who are owners of small and medium sized hospitals.

The drug stores in Kerala informed our members, that the supply of drugs to hospitals without  Drug Licence will stop wef 1.8.2010 as per the ORAL ORDERS of the Kerala Drugs Controller.

There are an equal number of modern medicine hospitals affiliated to the other organisations in Kerala. All the Ayurveda, Homeopathy and Dental Clinics and hospitals  will also come under the net. That takes the total number of Private Hospitals in Kerala to more than 6,000 directly under the threat of the Drugs Control Department.

The Drugs Controller has no statutaray right to impose Drugs Licence on Private Hospitals as per the Drugs & Cosmetics Act 1940, that he is authorised to safeguard. No other state in India is having this issue.

The Association — Qualified Private Medical Practitioners' Association —  has filed an SLP (C) No. 16581/2010 & 15171/2010 in the Supreme Court against this harassment by the Drugs Controller, Kerala Government & the Union of India. However, ignoring the SLP filed the Drugs Controller is implementing his decision orally through the Drug Stores in Kerala. The Drugs Controller, as such, is busy preparing the Counter Affidavit for the Supreme Court.  

The QPMPA was fighting this issue for the last 37 years with the Department and we are not ready to oblige, as long as we have the constitutional backing. We may even decide to close down all the Private Hospitals in the State to win our case. 

Indian democracy should not be allowed to function on the ignorance, whims and fancies of the officials entrusted to carry out constitutional duties.

Kindly do the needful. Thanking you.

Yours sincerely,

Dr. Kishore Kumar, State Secretary, QPMPA.

For more details visit our website www.qpmpa.org

QPMPA to Protect
The Drugs & Cosmetics Act, 1940 & Rules 1945
& The Pharmacy Council Act, 1948

Private hospitals getting ready for a SHUT DOWN

6,000 small & medium healthcare institutions will be affected

The Drugs Controllers of Kerala and the private hospitals here are on a warpath from 1974 onwards.

The Drugs Controllers of Kerala for the last 36 years were pestering the private hospitals to take Drug Licence to run the pharmacies in the hospitals.

Rule 65 of the Drugs & Cosmetics Act deals with Drug Licences. This rule has 22 sub-rules, 92 clauses/sub-clauses and is spread over 10 pages in the Rules book. Even a learned Judge will find it difficult to understand it in one sitting. That being the case, we can ignore the dilemma of the pharmacist in the Drugs Department.

The Drugs Controller of Kerala wants all Private hospitals to take a Drug Licence on the strength of Rule 65. Sub-rule (5) Clause (1) sub-clauses (a), (b), (i.e. - R. 65. (5) (1) (a), (b) – copied below.)

Rule 65 of the Drugs Act

Rule 65. Condition of licences. — Licences in Forms 20, 20-A, 20-B, 20-F, 20-G, 21 and 21-B shall be subject to the conditions stated therein and to the following general conditions—

Sub-rule: (1) Any drug shall, if compounded or made on the licensee’s premises be compounded or made by or under the direct and personal supervision of a registered Pharmacist.

XXX

Sub-rule: (5)(1) Subject to the other provisions of these Rules the supply of a drug by wholesale shall be made against a cash or credit memo bearing the name and address of the licensee and his licence number under the Drugs and Cosmetics Act in which the following particulars shall be entered —

(a) the date of sale,

(b) the name, address of the licensee to whom sold and his sale licence number. In case of sale to an authority purchasing on behalf of Government, or to a hospital, medical, educational or research institution or to a Registered Medical Practitioner for the purpose of supply to his patients the name and address of the authority, institution or the Registered Medical Practitioner as the case may be,

The highlighted part of the rule cited clearly says that a licence is not required for doctors and hospitals and allied institutions.

However, that being the truth, the Drugs Controller is very adamant to implement Drug Licence on Private Hospitals by orally ordering Drug Stores not to supply drugs to hospitals without licence. The simple reason being, that there is no legal backing.

The word Hospital

The word “Hospital” is used at 56 places in the Drugs & Cosmetics Act & Rules and nowhere is it said that a hospital must have a drug licence to dispense medicines from the hospital. The truth as per the Drugs Act & Rules is that the Private Hospitals need not even have a Pharmacist to dispense the medicines. A copy of the Drugs Act and Rules can be downloaded from the web.

Pharmacist a must

However, to the great relief of the Pharmacists, the friends of the Officials in the Drugs Departments, the Drugs Act & Rules insist that a registered Pharmacist must be there in ALL GOVERNMENT HOSPITALS.

To place a registered pharmacist legally in a private hospital, the Drugs Act must be amended. Amending the Drugs Act is no simple matter and so the backdoor entry techniques.

Pharmacy Act

The Pharmacy Act governing the Pharmacists is also against the Pharmacists when it comes to their services in Private Hospitals. The relevant section is copied from the Pharmacy Act —

“S. 42. Dispensing by unregistered persons.—(1) On or after such date as the State Government may by notification in the Official Gazette appoint in this behalf, no person other than a registered pharmacist shall compound, prepare, mix, or dispense any medicine on the prescription of a medical practitioner;

Provided that this subsection shall not apply to dispensing by a medical practitioner of medicine for his own patients, or with the general or special sanction of the State Government, for the patients of another medical practitioner.”

Conditions in Drug Licences

One important condition attached to Drug Licence is that, the licensee must honour the demand for drugs from hospitals and registered medical practitioners. The relevant part is copied.

Schedule A of the Drugs Rules 1945

FORM 20B [See rule 61 (1)]

Licence to sell, stock or exhibit or offer for sale, or distribute by wholesale, drugs other than those specified in Schedules C, C (I) and X

Conditions of Licence

1. This licence shall be displayed in a prominent place in part of the premises open to the public.

2. The licensee shall comply with the provisions of the Drugs and Cosmetics Act, 1940 and the Rules thereunder for the time being in force.

3 (i) No drug shall be sold unless such drug is purchased under a cash or credit memo from a duly licensed dealer or a duly licensed manufacturer.

(ii) No sale of any drug shall be made to a person not holding the requisite licence to sell, stock or exhibit for sale, or distribute the drug.

Provided that this condition shall not apply to the sale of any drug to—

(a) an officer or authority purchasing on behalf of Government, or

(b) a hospital, medical, educational or research institution or a registered medical practitioner for the purpose of supply to his patients, or,

Unfortunately, the Drugs Controller so eager to impose a Drug License out of the way is having some ulterior motives and so conveniently failed to see what is printed in all the certificates tthey issue o Drug Stores.

The cited conditions are also in:

FORM 20BB (See rule 62-D)  -- Licence to sell, stock or exhibit or offer for sale by wholesale, or distribute drugs other than those specified in Schedule C and Schedule C (1) to the Drugs and Cosmetics Rules, 1945 from a motor vehicle 

FORM 20D (See rule 67-C) -- Licence to sell ... Homoeopathic medicines by wholesale

FORM 20G [See rule 61(3)] -- Licence to sell, stock or exhibit or offer for sale, or distribute by wholesale drugs specified in Schedule X

FORM 21B [See rule 61(2)] -- Licence to sell, stock or exhibit or offer for sale, or distribute by wholesale drugs specified in Schedules C and C (1) excluding those specified in Schedule X

FORM 21BB [See Rule 62-D] -- Licence to sell by wholesale or to distribute drugs specified in Schedule C and Schedule C (1) to the Drugs and Cosmetics Rules, 1945 from a motor vehicle.

The bureaucratic misbehaviour an insult to the Court

We regret to note that when a case is there in the Apex Court, as reported in the media, against or challenging the directives of the Kerala High Court, the Drugs Control Department should not have gone ahead with the orders of the High Court. If we had at least one official in the Health Department who has respect for the Judiciary, or the constitution of India they would have waited for the verdict of the Apex Court before going ahead with the orders of the Kerala High Court.

The QPMPA (Qualified Private Medical Practitioners’ Association) has filed an SLP in the Supreme Court — SLP (C) Nos. 16581/2010.

The opposite parties in the case are the Union of India, Govt. of Kerala and the Kerala Drugs Controller. The Apex Court has requested the Opposite parties to file their Counters if they so desire in June 2010. (See Apex Court order dated 8 June 2010 -- http://judis.nic.in/temp/1517120101862010p.txt or visit http://www.qpmpa.org/news-and-events/11/25-special-leave-petition-16581-of-2010.html or http://www.qpmpa.org/)

Allegations on Hospitals

The allegation by Ms. Geetha, the Drugs Controller, is against facts and proves her ignorance of the Drugs and Cosmetics Act, 1940 and Rules, 1945.

Kindly refer Section 22 - Powers of Inspectors - of the D&C Act, 1940. (Visit http://www.qpmpa.org/component/content/article/1-latest/16-an-open-letter-to.html or www.qpmpa.org and read the open letter to CM and others of Kerala dated 22 May 2010.)

The Drug Inspectors are having vast powers to inspect every place where drugs or medicines are stored or used and are free to take any action prescribed. They can even call the Police to help.

The finding by our Hon’ble Health Minister can be ignored. She knows very well that no useful purpose will be served by wasting time to read the Drugs and Cosmetics Act having more than 600 pages. However, she would have become much wiser if she had read the few pages of the letter cited in the QPMPA website addressed to her also.

Ignorance of law a blessing for the Officials

In Indian democracy, ignorance of the Laws of the land is not an excuse for the ordinary citizens. On the other hand, that is a blessing for the Officials concerned. Every law applied to plunder the innocent public is something done in good faith by the officials and they cannot be penalised. A clause is there in every Act to protect erring officials in this country.

Stakes

If the Drugs Controller and the Health Ministry were acting from within the ambit of the Drugs Act and Rules, no one would have objected. Unfortunately, both the parties involved do have stakes and were acting illegally manipulating the Drugs & Cosmetics Act 1940, and Rules 1945 and the Pharmacy Act, 1948. Legally we are bound to protect it and will do that at any cost. For acting against the unlawful threats and dictates of some irresponsible Officers, we cannot be branded as criminals or outlaws. Kindly note that this war is 36-years old now.

That is why the Drugs Controller or the Government are reluctant to give written orders to hospitals or chemists and are happy with oral orders and media threats. A letter from the Secretary of the Druggist Association, Kottayam dated 23.4.2010 will prove that.

The judgment dated 25 March 2010 that saved Private hospitals

The request by the QPMPA in the said case was to equate private hospitals with the public hospitals and the learned Judges said a big ‘NO’ in WP (C) No. 38494/2003 (Y).

This big ‘NO’ was a real blessing in disguise. If the Court had agreed to our demands and equated private and public hospitals, that would have been the biggest insult for the medical profession.

Then, as obedient citizens, we are legally bound to appoint pharmacists in all private hospitals as done in Government hospitals as required under Item 5A in Schedule K. Nearly 10,000 Pharmacists would have found employment overnight! We are thankful to the High Court Judges. This was our second attempt to help pharmacist get jobs in private hospitals! The judiciary, however, was unfortunately not in favour of the pharmacists and we are helpless!

Who can interpret statutes?

Interpretation of statutes is effectively left to the discretion of the judge. In 1978, (British) Parliament passed the Interpretation Act to set out general rules for courts to interpret acts. Three rules had been developed accordingly to provide a framework of interpretation. These rules are Literal Rule, Golden Rule and the Mischief Rule. When compared, these rules are unalike so it is down to the discretion of the judge to apply which rule they see fit.

Usually the Literal Rule is applied and not hidden meanings —

“When the literal rule is applied the words in a statute are given their ordinary and natural meaning”, in other words the legislation is to be read literally and not to be analysed further for different meanings.

This rule does not call for further interpretation of an act and directly honours the intentions of the draftsman who wrote it, as stated by Lord Bramwell “...what is such an absurdity that you are to disregard the plain words of an Act of Parliament” in Hill V. East and West India Dock 1884.

A reading of the Open letter to the CM and others in the cited website - www.qpmpa.org will make all concerned wiser and we expect the Drugs Control Department to do what they are asked to do as per the statute they are to manage. Kindly do not manipulate it.

An appeal to all Private Hospital Owners in Kerala

The Drugs stores in Kerala has informed all the hospital owners that the Drugs Controller has orally directed all the Druggists and Chemists in Kerala not to supply medicines to Private Hospitals with effect from 1 August 2010.

We have two options — 1. Blindly obey the illegal dictates of the Drugs Controller lying down and swallow all that follows & 2. Down shutters.

Kindly cooperate when the time comes and act as directed. Let us stand united and prove that we do respect constitutional rights, have retained some self-respect and shall not take things lying down. Prove that we will shelve Medical Ethics, if required, the only language our masters understand!

Kindly blacklist Drugs Stores ignorant of their rights and duties. They have no respect for the Pharmacy profession.

Five simple questions before the Health Minister &
Drugs Controller, Kerala

1. What prevents private hospitals from taking a drug licence?

2. What are the relevant sections in the Drugs & Cosmetics Act applicable to doctors and hospitals to obtain a Drug Licence?

3. The Drugs & Cosmetics Act and Rules are applicable to the whole of India and how many states in India has imposed Drugs Licence on Private Hospitals of the strength of Rule 65 (5) (1) as applied in Kerala?

4. The Pharmacy Council and the Associations of Pharmacists, friends of the Drugs Controllers in Kerala, has come out with umpteen number of Press Conferences from 27 March 2010 till date from almost all the major towns of Kerala demanding the implementation of the Kerala High Court orders, showering insults on hospitals and doctors.

Have anyone of them ever bothered to read Rule 65. Condition of Licence — in the Drugs & Cosmetics Act, 1940 and Rules, 1945, in full, during the last 36 years of this controversy? (A copy of both Acts a must in all Drug stores!)

Or, have they at least read Rule 65 - Sub-rule (5), Clause (1) & sub-clauses (a) & (b) fully? If they have read that fully, Rule 65 (5) (1) (a) & (b), what do they have to say?

5. The final question& the most important — should a Jawan or Police constable must have an Arms Licence to carry an AK-47 or a pistol. Should they first refer the Arms Licence manual before carrying out the orders of the Officers concerned?

Violence not the remedy

That being what the statute says the Hospital owners cannot go and ransack the drug stores for non-supply of Drugs as we usually sees in our country in many issues affecting groups. The unfortunate situation is that we have no place to complain either.

It is unfortunate to note that the spineless Pharmacists running Drug Stores in Kerala, cannot read and understand what is written in the Licence they display proudly in every shop. Instead of exercising the legal rights available to them in the Drug Licence order, they are obediently passing on the ORAL ORDERS of irresponsible officials to doctors and hospitals who help them make 30% profit in every drug sold or must employ them. We have only sympathies for this group that has totally lost the Kshathriya blood!

Long Live Indian democracy. Jai Hind.