QUALIFIED PRIVATE MEDICAL PRACTITIONERS Vs. STATE OF KERALA

JUDGEMENT

(1.) The first petitioner is an Association of Qualified Private Medical Practitioners. Petitioners 2 to 6 are its members. The members of the first petitioner are running private hospitals/nursing homes. The grievance raised in this Writ Petition is concerning the insistence of the third respondent that the petitioners' hospitals should take out licence for dispensing medicines/drugs.

(2.) The brief facts of the case are the following. The manufacture and sale of drugs and cosmetics in India are governed by the Drugs and Cosmetics Act, 1940 (hereinafter referred to as 'the Act'). Under Section 18(c) of the Act, for sale of drugs, it is mandatory to obtain licence from the competent authority. The Central Government have been authorised by the Act to frame rules, granting exemption from various provisions of the Act in Chapter IV thereof subject to appropriate conditions. Section 18(c) comes under the said Chapter. The Central Government have framed Drugs and Cosmetics Rules, 1945, invoking its power under the provisions of the Act. Rule 123 of the Drugs and Cosmetics Rules, 1945, deals with the exemption. The said rule states that the drugs specified in Schedule 'K' shall be exempted from the provisions of Chapter IV of the Act and the Rules made thereunder, to the extent and subject to the conditions specified in that schedule. Item 5 of Schedule 'K' exempts 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 medical practitioner, if it is specifically prepared with reference to the condition and for the use of an individual patient. The said item also specifies the conditions, subject to which the exemption is granted. Item 5A exempts drugs supplied by a hospital or dispensary maintained or supported by the Government or local body. The petitioners claim that they should also be included under the purview of Item 5A of Schedule 'K' of the aforementioned Rules.

(3.) When the local Drug Inspectors started inspecting their hospitals and pressed the petitioners to take licence, they moved the Government by filing a representation before the Hon'ble Chief Minister, on 27.10.1990. The said representation was forwarded by the Government to the third respondent. The third respondent replied to the first petitioner, by issuing Ext.P1 communication dated 6.12.1990. The first petitioner was informed that its members are not exempted from the liability to take licence. That order was challenged before this Court, by filing O.P. No. 2179 of 1991. The said Original Petition was disposed of by Ext.P2 judgment. This Court directed the Government to consider the matter, as undertaken by the learned Government Pleader. Later, the Government rejected the claim of the petitioners and the Drugs Controller granted time to the members of the first petitioner up to 30.4.1995 to take licence. This is evident from Ext.P3 communication issued by the third respondent to the Secretary of All Kerala Chemists & Druggists Association. By Ext.P3, the Secretary of All Kerala Chemists & Druggists Association was advised to inform its members to quote the Drug Licence numbers of the hospitals in the invoice/bills issued for supply of medicines/drugs. The petitioners challenged Ext.P3 before this Court. The said challenge was repelled by a Division Bench of this Court, by the decision reported in Thomas v. Union of India, 2000 2 KerLT 459. Though the Original Petitions were dismissed, certain directions adverse to the Government were also issued in that judgment. So, both sides appealed before the Supreme Court, challenging the said decision. The Apex Court, by Ext.P4 order permitted to withdraw the Writ Petitions, with liberty to file fresh Writ Petitions, with proper pleadings. In the light of Ext.P4, the present Writ Petition is filed, seeking the following reliefs: