To
Honorable Dr Harshvardhan
Minister of Health and Family welfare
New Delhi
Re; Appeal for Amendment in Drugs & Cosmetic Act 1940 and Rules, 1945
Sir,
Medicos Legal Action Group is a Registered Trust formed by few doctors from all over the Country to look after interests and welfare of MBBS doctors and take legal action where needed.
We have received multiple complaints from individual doctors running clinics, small nursing homes managed by husband wife doctor couple and small multispeciality hospitals regarding harrasment at hands of drug inspectors under the provisions of Drugs & Cosmetic Act. Sir Small and Medium Health Care Establishments (SMHCE) provide more than 75-80 % of healthcare needs nationwide. These establishments are run by qualified Allopathic doctors without any Government support, subsidy or relief. These medical entrepreneurs usually have their residences in part of the same premises which has the clinical establishment and it may be self owned or rented.
Sir these SMHCEs have to tackle emergencies at all odd hours and need to stock medicines to give or administer to their own patients. It is also mandatory for all MBBS doctors to attend to any emergency brought to them and treat them to the best of their ability within resources available by law as laid down in various Supreme Court judgments. Some of these SMHCEs also routinely dispense medicines for their own OPD patients usually in small towns and villages. Even in cities doctors practicing in suburbs or colonies have to traditionally dispense medicines to their patients on payment. The doctors who dispense medicines are usually dealing with lower socioeconomic strata patients who cannot pay separate consultation fee to doctors. None of the SMHCEs (for whom this representation is being made) maintains a open Shop selling drugs to persons who are not patients of the SMHCE
Schedule K(5) of drugs and cosmetic rules 1945 has provided specific exemption to registered medical practitioner from obtaining a drug license to supply drug to his or her own patient. Despite this specific exemption there is confusion in its interpretation as to whether the exemption also extends to two or more registered medical practitioners working in same premises. Schedule K(5A) provides exemption to Government hospitals and dispensaries from need of drug license. The discrimination between Government and Private dispensaries and clinics is violative of Article 14 as well as Article 19 of Indian Constitution.
Taking advantage of this confusion unscrupulous drug Inspectors have been threatening doctors all over the country into paying “facilitation charges”.
We request you to consider an Amendment to the Drug and Cosmetic Rules Schedule K(5) to specify that “Drugs provided by Registered Medical Practitioners and hospitals with less than 25 beds to their own patients or any drug…………” This single line amendment in the rules will benefit lacs of doctors and their patients alike. We will be extremely grateful for your attention in the matter.
Thanking you
Yours sincerely
(Dr Neeraj Nagpal)
Convenor
Medicos Legal Action Group
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