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The Drugs Controller General of India (DCGI) Dr GN Singh has directed the accompaniment drugs controllers to added strengthen the authoritative ascendancy at retail auction outlets in the country to ensure that drugs are dispensed by the retail chemists in acquiescence to the accoutrement of Drugs and Cosmetics Rules.



Concerned over the growing violations of Rules by the chemists and druggists beyond the country, Dr Singh asked all the accompaniment biologic controllers in the country to absolute the Biologic Inspectors to accomplish abruptness inspections of chemist shops in their corresponding jurisdictions to ensure that the altitude of licences are complied with.  “The Chemist and Druggist Associations in your States may additionally be sensitized to ask their associates to accede with the accoutrement of the Drugs and Cosmetics Rules to abstain activity beneath the Drugs and Cosmetics Act for the violations of the accoutrement of the Drugs and Cosmetics Act and Rules fabricated thereunder”, the DCGI in his charge said.

A retail chemist is a basic articulation in the administration alternation of drugs from area drugs ability to the consumers. The chemists accountant beneath the Drugs and Cosmetics Rules 1945 are appropriate to accede to the assorted altitude of licence(s) which authorises them to affect the sales of drugs. The rules 65 of the said rules appoint in detail assorted requirements which are appropriate to be complied with by the licensees as altitude of the licence(s). It is accordingly important that the chemist licenced for retail auction accede with the altitude of the licence assigned for the purpose, the DCGI said.

The supply, contrarily than by way of broad dealing, of any biologic supplied on the decree of a Registered Medical Practitioner shall be accomplished alone by or beneath the claimed administration of a registered Pharmacist.   The accumulation of any biologic added than those defined in Schedule X on a decree of a Registered Medical Practitioner shall be recorded at the time of accumulation in a decree annals distinctively maintained for the purpose and the consecutive cardinal of the access in the annals shall be entered on the prescription.



Besides, the accumulation by retail of any biologic shall be fabricated adjoin a cash/credit announcement and annal of acquirement of a biologic advised for auction or awash by retail shall be maintained by the licensee.   Substances defined in Schedule H or Schedule X shall not be awash by retail except on and in accordance with the decree of a Registered Medical Practitioner and in the case of substances defined in Schedule X, the prescriptions shall be in duplicate, one archetype of which shall be retained by the licensee for a aeon of two years, the DCGI said.

No being dispensing a decree absolute substances defined in Schedule H or X, may accumulation any added preparation, whether absolute the aforementioned actuality or not, in lieu thereof.   Substances defined in Schedule X kept in retail boutique or bounds acclimated in affiliation therewith shall be stored, beneath lock and key in buffet or drawer resewed alone for the accumulator of these substances.  No biologic shall be awash or abounding by the licensee afterwards the date of cessation of authority recorded on its container, characterization or wrapper, or in abuse of any account or administration recorded on such container, characterization or wrapper.  

No biologic advised for administration to the medical profession as chargeless sample or drugs meant for burning by the Employees’ Accompaniment Insurance Corporation, the Central Government Health Scheme, the Government Medical Stores Depots, the Armed Forces Medical Stores or added Government institutions, which bears a appropriate mark or any inscription on the biologic or on the characterization added to the alembic thereof advertence this purpose shall be awash or abounding by the licensee on his premises.  Accumulation of drugs defined in Schedule X shall be maintained separately, the DCGI charge said.

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