The Drugs Controller General of India (DCGI) Dr GN Singh has directed the state drugs controllers to further strengthen the regulatory control at retail sale outlets in the country to ensure that drugs are dispensed by the retail chemists in compliance to the provisions of Drugs and Cosmetics Rules.

Concerned over the growing violations of Rules by the chemists and druggists across the country, Dr Singh asked all the state drug controllers in the country to direct the Drug Inspectors to make surprise inspections of chemist shops in their respective jurisdictions to ensure that the conditions of licences are complied with.  “The Chemist and Druggist Associations in your States may also be sensitized to ask their members to comply with the provisions of the Drugs and Cosmetics Rules to avoid action under the Drugs and Cosmetics Act for the violations of the provisions of the Drugs and Cosmetics Act and Rules made thereunder”, the DCGI in his directive said.

A retail chemist is a vital link in the distribution chain of drugs from where drugs reach to the consumers. The chemists licensed under the Drugs and Cosmetics Rules 1945 are required to comply to the various conditions of licence(s) which authorises them to affect the sales of drugs. The rules 65 of the said rules prescribe in detail various requirements which are required to be complied with by the licensees as conditions of the licence(s). It is therefore important that the chemist licenced for retail sale comply with the conditions of the licence prescribed for the purpose, the DCGI said.

The supply, otherwise than by way of wholesale dealing, of any drug supplied on the prescription of a Registered Medical Practitioner shall be effected only by or under the personal supervision of a registered Pharmacist.   The supply of any drug other than those specified in Schedule X on a prescription of a Registered Medical Practitioner shall be recorded at the time of supply in a prescription register specially maintained for the purpose and the serial number of the entry in the register shall be entered on the prescription.

Besides, the supply by retail of any drug shall be made against a cash/credit memo and records of purchase of a drug intended for sale or sold by retail shall be maintained by the licensee.   Substances specified in Schedule H or Schedule X shall not be sold by retail except on and in accordance with the prescription of a Registered Medical Practitioner and in the case of substances specified in Schedule X, the prescriptions shall be in duplicate, one copy of which shall be retained by the licensee for a period of two years, the DCGI said.

No person dispensing a prescription containing substances specified in Schedule H or X, may supply any other preparation, whether containing the same substance or not, in lieu thereof.   Substances specified in Schedule X kept in retail shop or premises used in connection therewith shall be stored, under lock and key in cupboard or drawer resewed solely for the storage of these substances.  No drug shall be sold or stocked by the licensee after the date of expiration of potency recorded on its container, label or wrapper, or in violation of any statement or direction recorded on such container, label or wrapper.  

No drug intended for distribution to the medical profession as free sample or drugs meant for consumption by the Employees' State Insurance Corporation, the Central Government Health Scheme, the Government Medical Stores Depots, the Armed Forces Medical Stores or other Government institutions, which bears a distinguishing mark or any inscription on the drug or on the label affixed to the container thereof indicating this purpose shall be sold or stocked by the licensee on his premises.  Supply of drugs specified in Schedule X shall be maintained separately, the DCGI directive said.