The Drugs and Cosmetics Act, 1940 deals with maintaining the quality of cosmetics and drugs. The act establishes the board of experts to advise the central and the state government related to technical matters. The Drugs and Cosmetics Act, 1940 provides guidelines about the distribution, manufacture, import and sale of drugs and cosmetics and drugs. The act also covers the Ayurveda, Siddha and Unani drugs and the provisions related to the same.
Drugs and Cosmetics act, 1940
The Drugs and Cosmetics Act, 1940 got enacted to regulate the import, manufacture and distribution of medicine in the country. The act got passed on April 10, 1940. The motto behind the enactment of this act is to ensure that the drugs and cosmetics sold in India are safe, effective and meet the quality standards.
The drugs and cosmetics act maintains the quality of cosmetics and drugs and establishes a board of technical experts that can advise the Central and state government to make guidelines about the manufacture, distribution, import and sale of cosmetics and drugs. It also regulates the Ayurveda, Siddha and Unani drugs.
Objective of the drugs and cosmetics act
The Drugs and Cosmetics Act was passed with the primary goal to allow the import, manufacture, distribution, and sale of drug cosmetics. It governs the import of medication and ensures that no substandard drug enters India. The act also forbids the manufacture of defective or forbidden drugs.
The act mandates the sale and distribution of pharmaceuticals only by trained and competent people. It also covers the sale, distribution and manufacture of Ayurvedic, Siddha, Unani and homoeopathic drugs.
The provisions governing the import, manufacture, sale and distribution of cosmetics are also governed by the Drugs and Cosmetics Act, 1940.
The act empowers the competent authority to make special regulations to govern the preparation, standardisation and storage of biological and special products and prescribe how various classes of medication and cosmetics should be labelled and packaged.
Features of Drugs and Cosmetics Act, 1940
The Salient Features of Drugs and Cosmetics Act, 1940 are as follows:
- The act provides the maximum penalty of life imprisonment of Rs.10 Lakhs or thrice the value of the confiscated goods, whichever is more.
- Other than the Drug Controller’s Office, other gazetted officers are also authorised to prosecute under the Drug and Cosmetics Act, 1940.
- Among the offences under the act, some are cognisable and non-bailable.
- The act covers the specially designated courts for the trial of an offence under the act.
- The act has provisions for the compounding of minor offences.
Drugs and cosmetics defined
The drug under the Drug and Cosmetic Act means and includes all the medications used for both internal and external use in human beings or animals. It also includes all the substances used for diagnosis, treatment, mitigation, or prevention of any disease or disorder in humans or animals, including preparation applied to the human body to repel insects like mosquitoes.
A cosmetic is any object rubbed, poured, sprinkled or sprayed or inserted into the human body as a part of washing. Beautifying, to enhance attractiveness or alter appearance that includes the material used as a component of cosmetics.
What is sub-standard quality drugs and cosmetics?
Any Drugs or Cosmetics that does not qualify the quality standard and specification is known as Sub-Standard Quality Drugs or Cosmetics. The specifications and standards regularly get assessed, reviewed, and approved by the National Medication Regulatory Authority before the drug gets authorised for marketing.
What is misbranded drugs or cosmetics?
Misbranded Drugs get defined under Section 17 of the Drugs and Cosmetics Act, 1940.
A drug will get considered as Misbranded in the following situation:
- If the drug is coated, coloured, polished or powdered to conceal the damage or make it appear as of better quality than the drug is.
- The drug is not adequately labelled.
- The container or the labelled of the drug bears any design, statement, or logo that makes any false or misleading claims.
Misbranded Cosmetics get defined under Section 17C of the Drugs and Cosmetics Act, 1940. A cosmetic gets considered as Misbranded in the following situation:
- If the product contains unspecified colour.
- If the product is not labelled properly.
- If the label or container of the product bears any logo or design making any misleading or false claims
Drugs and Cosmetics Act 1940 Section 5 empowers the central government to constitute an advisory board known as the Drugs Technical Advisory Board. The board is responsible for advising the state government on technical matters.
- Drug Technical Advisory Board:
The advisory board consists of 18 members, out of which 8 members are ex-officio chairman, and out of the remaining ten, five-member get nominated, and the remaining five are elected members. The board chairman is the ex-officio chairman of the Director-General of Health Services.
The tenure of the nominated and elected member is three years and is eligible for re-nomination and re-election. The central government appoints the secretary of the board. Even in case of vacancy, the board can carry on with the board’s functions.
- The Central Drugs Laboratory
The central government establishes the Central Drugs Laboratory. The Director has the power to control and perform functions provided by the Drugs and Cosmetics Act, 1940.
The Central Government provides the functions of the Central Drugs Laboratory and the procedure for submission.
- Drugs Consultative Committee
To constitute an advisory committee, the power gets vested in the central government. The name of such committee shall be the Drug Consultative Committee. The committee primarily has to secure nationwide uniformity in the administration of the act. The committee is composed of two representatives who are the nominee of the Central Government and one nominee from each state.
Regulation about the import of drugs and cosmetics
- Standards of Quality
The term standard quality for imports is in concerning medicine and cosmetics means that medicine and cosmetics should comply with the specification of imports. The standards set by the Act get set out under the Second timetable. Section 12 and Section 13 of the Act grant the Central Government the power to make rules regarding testing and examination methods that can get used to assess the standard quality of the medication.
Section 10 of the Drugs and Cosmetics Act gives the power to the central government to ban the import of medicines that are not of standard quality or misbranded, adulterated or spurious. To import any product License is required. No drug or Cosmetic can get imported without a license in the country.
- Rule Making About Import of Drugs and Cosmetics
The central government can draw the laws related to the importation of medicinal products and cosmetics after the board’s consultation or recommendation. It includes regulations that define the drugs or class of drug or cosmetics for which a license gets issued for importation. The forms and conditions of the issuance, suspension or revocation of licenses and the fees payable are demanded and prescribed.
- Penalties for Importing Prohibited Drugs or Cosmetics
The Drugs and Cosmetics Act, 1940 Section 13that talks about the importation of adulterated drugs or cosmetics, is punishable by imprisonment for three years and fines up to three years. The fine could be up to five thousand rupees. In the case of medicine or cosmetics that include dangerous ingredients, the penalty is similar as prescribed.
Restriction about manufacture, sale and distribution of drugs and cosmetics
The restriction on the manufacture, sale and distribution of certain drugs and cosmetics of non-standard quality or misbranded, adulterated or spurious products gets imposed under Section 18 of the Drugs and Cosmetics Act, 1940.
In India, drugs and cosmetics from the manufacture, sale and distribution are as follow:
- If the drug or cosmetic is Sub-Standard Quality, Misbranded, Adulterated or Spurious
- When the drug belongs to the category of Patent or Proprietary Medicine
- If a drug claims to prevent, cure or mitigate any disease or ailment.
- If a drug or cosmetics gets manufactured in contravention to stipulations prescribed
- When the cosmetic comprises harmful or unsafe ingredients
- If the Manufacture, Sale and Distribution of drugs and cosmetics do anything against the provisions of this act.
- The stock of any drug or cosmetic that is either prepared or imported violates the act.
The exceptions to section 18
The Exception to Section 18 of the Drugs and Cosmetics Act.1940 are:
- Section 18 of the Act does not apply to the manufacturers of drugs in small quantities, provided the manufacturing is related to the analysis, test or examination of the drugs prescribed to a certain condition.
- The Central Government has the power to allow manufacturing, sale and distribution of drugs or cosmetics after consulting with the Drug Technical Advisory Board.
Power, role of an inspector and the procedure of inspection
According to Section 21 of the Drugs and Cosmetics Act, 1940, an inspector comes under the definition of the public servant. The Drugs and Cosmetics Act, 1940 section 22 deals with the Power of Inspector. The Drugs and Cosmetics Act, 1940 section 23deals with the Procedure of Inspectors.
The central and state government is empowered to nominate inspectors to inspect drugs and cosmetics with the necessary qualification.
The act provides the inspector with the power to inspect, conduct, search, examine samples, check call records etc. Therefore, the power to inspect the premises where the drug or cosmetic is manufactured, sold, stocked or exhibited or offered for sale or distribution is given to the inspector.
An inspector can also search any person who has secreted any drug or cosmetic or entered any other place of the same belief. The provisions of Cr.P.C. can also apply for search and seizure made by the authority.
The procedure in which an inspector has to inspect a place or property, or person, gets provided under section 23 of the Drug and Cosmetic Act,1940. It explains different ways of inspection under different scenarios.
Regulations about Ayurvedic, Siddha and Unani drugs
The act provides a separate mechanism for controlling, manufacturing, and selling Ayurvedic, Siddha, and Unani drugs. The Act has established a different board and committee for the Ayurvedic, Siddha and Unani Drugs.
A board specifically for the Ayurvedic, Siddha and Unani drugs is constituted under Section 33C of the Drugs and Cosmetics Act by the central government. The board deals with the Ayurvedic, Siddha and Unani, the Ayurvedic, Siddha and Unani Drug Technical Advisory Board. The board’s purpose is to advise the central and state government on the matters related to the regulation of ayurvedic, Siddha and Unani drugs and carry out any other function that is required to fulfil the purpose of the board.
The Control Mechanism for Ayurvedic, Siddha and Unani Drugs
The power to appoint the analyst and inspector qualified to act as a government analyst gets vested upon the central or the state government. Any person who has any financial interest in manufacturing or selling the drug or cosmetics cannot get appointed as a government analyst.
Drugs and cosmetics rules, 1945
The Drugs and Cosmetics Rules, 1945, were enacted to respond to the Drugs and Cosmetics Act, 1940. The rules classify the medicine as per the timetable and guide the storage, sale, display and prescription guidance for each timetable.
The Drugs and Cosmetic Rules, 1945 includes clauses that classify the drugs into the schedule and provide guidelines for storing, selling, displaying and prescribing each schedule. The guidelines for the storing, selling, displaying and schedules are prescribed under Rule 67 of the Drug and Cosmetics Rules, 1945. Rule 97 provides rules for labelling restrictions.
The Drug and Cosmetic Act, 1940 governs the law related to Drugs and Cosmetics. The act covers the essential aspects related to drugs and cosmetics. The restrictions get imposed on the manufacturers, sale and distribution of certain drugs and cosmetics, and the manufacturer. Everyone involved in any of the activities related to drugs and cosmetics is liable to comply with the provisions of this act. If anyone does not abide by the provision of the Drug and Cosmetic Act 1940, then he is liable to a penalty as provided by the act.
From time to time, the government amend the act as per the requirement of society. Thus, the Drugs and Cosmetics Act, 1940, being age-old legislation, still keeps on meeting the needs of society.
What are the duties of a government analyst?
- The samples of drugs or cosmetics are to be analysed and tested by the government analyst sent to him by the Inspector.
- The government analyst should forward research reports to the government from time to time. The information should give the analytical work and research for publication.
What is the required qualification to be a government analyst?
A person to be a government analyst should possess the qualification as prescribed by the government. And he must have a degree in Medicine, Ayurveda, Siddha, Unani System which should not be less than 3 years post-graduate experience in the analysis of drugs.
What are the Central Drug Laboratory under the Drugs and Cosmetics Act, 1940?
The Central Drug Laboratory, established in Calcutta, is under the director’s control appointed by the Central Government. The major function performed in the laboratory is to Analyse or test the drug or cosmetic sample sent by the customs collector or courts and many other functions as provided by the Act.
What are the classes of drugs prohibited from being sold?
- Misbranded, spurious, adulterated drugs that are not of standard quality.
- Patent or Proprietary goods with undisclosed formula.
- Expired Drugs