Suggestions for amendment of Rule 64 & Sch-N

Suggestions for amendment of Rule 64 and Sch-N of Drugs and Cosmetics Rules

Act Rule Law
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H. Mahapatra

The steps taken at present to amend Rule 65(15) is highly appreciated but legally it will be well accepted if suitable amendments are made simultaneously in Drugs and Cosmetics Rules (DCR) as follows:-

1-Rule 64(1)

Provided that in case of a pharmacy a license in Form F-20, 21 or 20F shall not be granted / perpetually valid, unless the Licensing Authority is satisfied that the requirements prescribed for a pharmacy in Schedule-N have been complied with:


For the purpose of this rule the term ‘Pharmacy’ shall not be held to mean and include every store or shop or other place where drugs are stocked, sold, distributed or supplied by way of retail sale under the supervision of Registered Pharmacist.

Also read: Safe disposal of unused medicines

2-Schedule N (proposed amendment)
[Rule 64(1)]


  1. Entrance-The front of pharmacy shall bear an inscription ‘Pharmacy’ in front.

ii) Premises-

a-Shall be well separated rooms for private use

b-Well-built, well-lit, well ventilated and provided with temperature controlled refrigerator for proper storage of required biological drugs/drugs

c-suitable racks are to be provided to store drugs

d-the height of the premises shall be atleast 2.5 meters after false ceiling e-lights are to be concealed in the false ceiling

f-floor should be smooth and washable surface devoid of holes, cracks and cervices g-Should have an ample supply of drinkable water

h-Should be provided with Dispensing bench / show case,the top of which shall be covered with washable and impervious material like lamination or plastic.

i-separate storing provision of veterinary drugs with proper labeling

j-separate storing provision with lock and key for storing Schedule-X drugs.

k-separate provision for keeping expired drugs away from seal-able stocks with proper label.

Also read: Self audit of Medical Store

iii)  General provisions:-

a-pharmacy shall be conducted under the continuous personal supervision of a Registered Pharmacist

b-the Registered Pharmacist shall always put on clean white overalls attached with a badge having his name and registration number

c-bio-metric provision shall be made for duration of supervision of Registered Pharmacist

d-all records and registers shall be maintained in accordance with laws in force

e-the premises and fittings of the pharmacy shall be properly kept and everything shall be in good order and clean

f-Schedule H / H1 / X / Narcotics drugs shall be purchased against a property signed order with stamp of the pharmacy from duly licensed wholesaler only

g-A proper acknowledgement shall be given to the wholesaler towards receipt of Schedule H / H1 / X / Narcotics drugs purchased against a valid purchase invoice

h-payments shall be made to wholesaler’s against purchase of drugs through bankers cheque / draft / RTGS or NEFT

Also read: Law relating to Smokeless Tobacco Products


The above requirements are subject to modifications at discretion of the Licensing Authority, if he / she is of the opinion that regard to the nature of the drugs stocked / solid / distributed by the licensee.

It is necessary to relax the above requirements or to impose additional requirements in the circumstances of a particular case.

The decision of the Licensing Authority in the regard shall be final.

The above suggestion may kindly be taken into consideration while proposing draft notification to Govt. of India.

Disclaimer: This is the personal opinion of the author and anyone may have a different opinion.

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