Drug and Cosmetics Act 1940 and Rules 1945

Introduction of Drug and Cosmetics Act 1940 and Rules 1945:-

The main aim of the Drug and Cosmetics Act 1940 and Rules 1945 is to maintain the import manufacture, distribution, and sales of drugs and cosmetics.

Continuous use of cosmetics in luxury items proves to be harmful as they may contain harmful ingredients. Therefore there is a need to control cosmetics.

This act verifies that the drug and cosmetics should be manufactured, distributed, and sold only by a qualified person having a license for this purpose. The central and state drug control authorities are also recognized to control these actions.

Definition of Drug and cosmetics Act 1940 and rules 1945:-

What is Drugs:-

All medicines for internal and external use of human beings or animals and all substances intended to be used in the diagnosis, treatment, or prevention of any disease or disorders.

Including preparation applied on the human body for repelling insects like mosquitoes. Such substance (Other than food) intended to affect the structure or any function of the human body or intended to be used for the destruction of insects that cause disease in human beings or animals as may be specified from time to time by the central government by notification in the official gazette.

Patent medicine / Brand: – Patent medicine refers to a remedy whose formula is on by the manufacturer and which is marketed usually under a name registered as a trademark.

In relation to the Ayurvedic, Siddha, Unani system of medicine all formulations contain only such ingredients mentioned formally described in the authoritative books of the Ayurvedic, Siddha, Unani system of medicines specified in the first schedule but do not include medicines which are administered by the parenteral routes.

Mis-branded drug:-

A drug is deemed to be Mis-branded.

It is so colored, coated, powdered, or polished that damaged. If it is made to appear of better or therapeutic value then it is really.

If it is not labeled in the prescribed manner.

If it is a label or container the drug bears any statement, design, or device which makes any false claim for the drugs or which is false or misleading in any particular.

Superior cosmetics Or Mis-branded Cosmetics:-

If it contains a colour which is not prescribed.

If it is not labeled in the prescribed manner.

If the label or container bears any false statement.

Adulterer drugs:-

If it consists of any filthy, decomposed substance.

If it has been prepared, packed, or stored under insanitary conditions where it may be injurious to health.

Spurious drug:-

Same as adultered drugs.

Sale of Drugs

Sale is the process passing of a drug from the manufacturer to the consumer. The different kinds of license issuable for wholesale and retail of drugs.

There are two types of selling:-

Wholesale
Retail

The process of passing drugs from manufacturer to consumer is termed sale. In India selling drugs was an open trade till 1940 hence, anyone could sell, compound, or dispense drugs without any restriction after the implementation of the Drugs and Cosmetics Act 1940, the selling of drugs became restricted practice and only the licence individual can be involved in a the wholesale, retail, compounding, dispensing of drugs.
Licences are required for wholesale or distribution from a motor vehicle retail sale of drugs and a separate licence is needed for each promise where drugs are sold.

Retail distribution of drugs: – Retailing of drugs is done through shops or by vendors certain important and basics for retailing selling of drugs or as follows.

Retail sale from shops: – There are following rules for the retail sale from shops.

Facilities as per schedule N.
Purchase only from licensed wholesaler.
No sales of specified drugs (Schedule H and Schedule X) without a prescription.
A separate license for Schedule C, C1, and X.
Sale under qualified supervision.
Records
Inspections
Sale of specified household drugs from drug stores but schedule N and sale under qualified supervision not applicable.

Retail sales of drugs can be done from the following shops:-

Chemist and druggist (Followed by registered Pharmacist but do not compound drugs)
Pharmacies (Followed by registered Pharmacists and engaged in the compounding of drugs)
Drug store (Drug stores which do not have a registered Pharmacist and sell drugs specified as household remedies)

Retail sale from Vendors:- Sometimes drugs are sold by vendors who do not have a fixed place of business but have been granted license by the licensing authority to conduct business in a particular area. Persons who distribute drugs in a sparsely populated areas with no other agencies for drug distribution or travelling agents of firms dealing in the drug are issued license to sell drugs. The license to sell drugs are issued only for drugs other than those specified in Schedule C and C1.

Wholesale distribution of drugs:-

A wholesaler with a valid trade license can approach the drug manufacturer to supply medicines for selling to the retailers.

Following are the conditions of granting the licence for wholesale of the drug.

Adequate infrastructural facilities
Records
Sale only to licensed retailers
Inspection

Wholesale for fixed premises:-

Wholesale of drugs can be done from fixed premises or by motor vehicle. A separate license is needed for the wholesale of drugs under schedules C & C1.

Wholesale of Schedule C and C1 Drugs:- there are the following conditions –

The license must have adequate premises not less than 10m2 in area, equipped with adequate facilities for storage of drugs to preserve their potency.
The drug should be sold to a person with license to retail them.
If the license desires to self any other categories of drugs be should seek permission from the licensing authority.

Records of all purchases and sales of Schedule C drugs by wholesale dealing should be maintained under the following-

The date of purchase and sale
Name and address
Name and quantities of drugs and their batch number.
Name of the manufacturer of the drugs.

Procedure for sale, Purchase, and Storage of drugs:-

In different kinds of establishment for the sale of drug there are following:-

Dispensing and compounding of drugs
Sale of Schedule X and Schedule H drugs
Supply/Sale of Schedule C drugs.
Supply Sale of other drugs.
Records of purchase of drugs
Storage of Schedule X drugs with expiry dates.
Storage of veterinary medicine
Drug stores.

Labeling of the drugs

Class & Nature of Medicine in which contained	Particulars that should appear on the label
Schedule C In Original form	1. Proper name of the substance along with the name of any patent. 2. License number under which manufactured or imported. 3. Batch number 4. Statement of potency in unit. 5. Name and address of the manufacture of finical products. 6. The expiry date 7. The manufacture date 8. Name and percentage of added antiseptics
Schedule – C1 and their preparation including combination with other drug.	1. The Manufacture date 2. The expiry date 3. Import license number
Schedule F & F1	The prescribed name
Schedule G Medicine made up ready for internal use in the treatment of human elements.	The word caution it is dangerous to take this preparation expert under medical supervisions should be Cleary printed and surrounded by a line with in which there should be no other words.
Schedule H Medicine for internal use of human beings	1. Simple should be clearly displayed on the left top corner of the label. 2. Schedule H drug warning to be sold by retain on the prescription of a registered medical practitioner only
Schedule X Medicine for internal use of human beings	1. Schedule X drugs/ Warning to be sold by retail on the prescription of the RMP. 2. Symbol X given conspicuously in red
Schedule P any drug	1. The manufactured date 2. Expiry date
Schedule W Single ingredient.	1. Proper name (No trade name)