What are Drugs and Cosmetics?
Drugs are necessary to save life or to restore or preserve health. It is, therefore, imperative to ensure that the consumers receive drugs of quality and at reasonable price. The Drugs Rules were framed in 1945 to give effect to the provisions of the Act. Regulation of import of drugs is the responsibility of the Central Government whereas licensing of manufacture, sale and distribution of drugs in the country is the responsibility of the State Governments but their enforcement is governed both by central as well state governments Cosmetic means any article intended to be rubbed,poured,sprinkled or sprayed on, or introduced into, or otherwise applied to, the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and includes any article intended for use as a component of cosmetic.
What are Misbranded Drugs and Cosmetics ?
A drug or cosmetic shall be deemed to be misbranded,? (a) if it is so colored, coated, powdered or polished that damage is concealed or if it is made to appear of therapeutic value than it really is; or (b) if it is not labeled in the prescribed manner; or (c) if its label or container or anything accompanying it bears any statement, design or device which makes any false claim for the drug or which is false or misleading in any particular.
What is an Adulterated Drug ?
A drug shall be deemed to be adulterated,? (a) if it consists in whole or in part, of any filthy, putrid or decomposed substance; or (b) if it has been prepared, packed or stored under insanitary conditions whereby it may have been contaminated with filth or whereby it may have been rendered injurious to health; or (c) if its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health; or (d) if it bears or contains, for the purposes of colouring only, a colour other than one which is prescribed; or (e) if it contains any harmful or toxic substance which may render it injurious to health; or (f) if any substance has been mixed therewith so as to reduce its quality or strength.
What is a Spurious Drug or Cosmetic?
A drug or cosmetic shall be deemed to be spurious (a) if it is manufactured under a name which belongs to another drug or cosmetic ; or (b) if it is an imitation of, or is a substitute for, another drug or cosmetic or resembles another drug or cosmetic in a manner likely to deceive or bears upon it or upon its label or container the name of another drug or cosmetic unless it is plainly and conspicuously marked so as to reveal its true character and its lack of identity with such other drug or cosmetic ; or (c) if the label or container bears the name of an individual or company purporting to be the manufacturer of the drug , which individual or company is fictitious or does not exist.
Who can get the test done in case of a doubt regarding nature of a Drug or Cosmetic?
Any purchaser of drug or cosmetic or any recognized consumer association, whether such person is a member of that association or not, shall, on application in the prescribed manner and on payment of the prescribed fee, be entitled to submit for test or analysis to a Government Analyst any drug 3 or cosmetic purchased by him .
Whether Free Samples can be sold?
No drug intended for distribution to the medical profession as free sample which bears a label on the container and no drug 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 chemist on his premises.
What is Maximum retail price? Can a medicine be sold at a lower price than the MRP?
The printed MRP (Maximum Retail Price) is the maximum payable amount. However, a medicine can be sold below this price.
If a retailer sells medicines by breaking packing, what price can he charge ?
If a retailer sells loose quantity (unpacked) the price of such medicine should not exceed pro-rata amount of the price printed on the label of the container.
Can a customer demand a receipt?
Every chemist/ retailer is required to issue a receipt for sale of medicines and maintain the copies of cash/ credit memos.
Who are the national level, state level and district level authorities that are responsible for enforcement of fixed prices?
The National Pharmaceutical Pricing Authority, the FDA/ Drugs Controller of the State, and Drugs Inspector of the District are the enforcing authorities at National / State/ District Levels.
Who are the local level authorities to whom the compliant can be made ?
The area State Drug Controller/Joint Drug Controller/ Deputy Drug Controller/Assistant Drug Controller / Drugs Inspector etc. of the state concerned. Complaints can be lodged with anyone of these.
Where can a consumer lodge a complaint regarding overcharging and quality of drugs sold ?
Charging more than printed MRP of a medicine attracts the penal provisions of Drugs Price Control Order, 2013. Quality aspects of a medicine attract the provisions of Drugs and Cosmetic Act, 1940. The FDA/ Drugs Control Organization of the State is the enforcing agency of Drugs and Cosmetics Act and DPCO at state level. Therefore, all complaints on prices as well as quality of medicines can be lodged with the Drugs Inspector of the District or the State Drug Controller. Complaints regarding violation of prices can be lodged with NPPA directly also.
What is the essential/ mandatory information that is required to be printed on the label of the medicine pack ?
o Name of the formulation o Composition of the formulation o Pack Size o Address of the manufacturer o Manufacturing License Number o Date of manufacture o Expiry Date o Maximum Retail Price (inclusive of all taxes) etc.