INTRODUCTION
India is racing ahead of the curve in all areas of technology, including the medical sciences. In the decades since the COVID-19 outbreak, India has actively contributed to and pioneered numerous health and safety advancements. However, the law needs to back all of these procedures, and it must adapt in real-time to keep up with the rapidly developing area of medicine. “The Drugs and Cosmetics Act,1940 (DCA)”, is one of the laws that regulate the production, sale, and import of pharmaceuticals in India[1]. This act was later followed by “The Drug and Cosmetics Rules, of 1945[2]”, which classified drugs into different schedules and enacted standards for the purpose of distribution, dispensing, and storing of different types of medications.
OBJECTIVES OF THE DRUG AND COSMETIC ACT, OF 1940
The purpose of “The Drugs and Cosmetics Act” is to prevent medical technology and pharma companies from drug alteration and to hold them liable for any negligent or substandard services they may have supplied to patients or consumers.
The following are some other purposes for the formation of this act:
- Regulating only the licensed drug and cosmetics for sales, imports, and other drug distributions.
- To ensure that only licensed professionals are engaged in the import, sale, or distribution of pharmaceuticals and personal care products.
- Maintaining a good level of medical care to prevent any substandard quality.
- Control over Ayurvedic, Siddha, and Unani pharmaceutical manufacturing and distribution.
- To establish an Allopathic and Allied “Drugs Technical Advisory Board (DTAB)” and a “Cosmetics Drugs Consultative Committee (DCC)”.[3]
DRUGS
The drug is defined under Section 3[4] of the act. It includes the following categories:
- All such medicines which humans or animals use for “external or internal use and also the substance that is used for diagnosis, treatment, or prevention of any illness or health problem”. Insect repellents that can be applied directly to the skin are included in this category as well.
- Any substance besides food, that affects the function or structure or any disinfectants that prevent diseases in humans and animals that the Central Government specifies.
- The Substance that is used to make drugs includes gelatine capsules[5].
COSMETIC
Cosmetic is also defined in section 3[6] which applies to items that are “intended to be sprayed, poured, rubbed, or sprinkled on, introduced into, or applied on the human body or any portion that is used for purifying, beautifying, enhancing attractiveness, or altering the appearance.” All products with the sole purpose of enhancing one’s appearance are included under cosmetics.
AYURVEDIC, SIDDHA, OR UNANI DRUGS
Section 3(a)[7] includes “Ayurvedic, Siddha, or Unani” drugs as all such medicines which humans or animals use for external or internal use and also the substance that is used for the purpose of diagnosis of a disease or its treatment, or prevention of such illness. According to DCA, all these medications should be made exclusively using the formulations detailed in the official texts of the “Ayurvedic, Siddha, and Unani”.
PATENT OR PROPRIETARY MEDICINE
“Patent or Proprietary Medicine” is defined under Section 3(h)[8] as:
- “All formulations containing only the ingredients mentioned in the formula described in the authoritative books of the Ayurvedic, Siddha, or Unani systems of medicine specified in the First Schedule to the Act,” except the parenteral drugs.
- A drug that is introduced in the form “ready for internal or external administration” of people or animals in any other system of medicine, including allopathy.
DRUGS TECHNICAL ADVISORY BOARD (DTAB)
By the terms of this Act, the Central Government created this statutory board to provide advice to the Central and State Governments on matters related to the Act and to develop guidelines for various formulations as requested by the Central Government. The “Drugs Controller General of India” is the DTAB’s Member Secretary, and the Director General of “Medical and Health Services,” and the Indian government, is the board’s Chairman.
LICENSING AUTHORITY
Licensing authorities are responsible for the insurance of licenses for the distribution and sale of pharmaceutical drugs and cosmetics within a given territory. Such authorities should have a graduate degree in pharmacy or medicine with a specialization in “pharmacology”. Furthermore, they need to have worked in the pharmaceutical industry for at least five years.[9]
Licensing authorities have the following authorities:
- To investigate all possible drug dealers in his territory.
- To make sure the terms of the license are met lawfully
- To acquire and, if necessary, ship imported products to a lab for inspection or testing.
- Investigate complaints and grievances.
- Maintain a written record of all work-related inspections and follow-up activities.
- To discover illegal drug transactions, it is vital to perform any inquiries and inspections that may be required.[10]
DRUGS AND COSMETICS RULES
Some sets of regulations have been developed to further strengthen “The Drugs and Cosmetics Act, of 1940,” which includes developments in the pharmaceutical business brought on by technical advances and other factors.
DRUG AND COSMETIC RULES, 1945
As a follow-up to “The Drugs and Cosmetics Act of 1940”, the Indian government passed the Drugs and Cosmetics Rules, in 1945. These rules divided medicines based on their sale, warehousing, medical use, etc. “The Drugs and Cosmetics Rules of 1945” classify medicines into schedules and provide regulations for how these medications should be kept, advertised, prescribed, and sold. The conditions of permits are laid down in Rule 67G[11]. Labelling requirements are laid out in Rule 97[12]. The Drugs Technical Advisory Board was also recognized as the highest decision-maker in all matters about the technical requirements of pharmaceutical products.[13]
CONCLUSION
Many new pharmaceutical companies have entered the market in recent years to turn a profit in the healthcare sector. As such, we have to prevent them from making a profit at the expense of public health. To ensure that the pharmaceutical sector in India is effectively regulated, a comprehensive law was enacted in 1940 called the Drugs and Cosmetics Act. It has developed and changed considerably to adapt to new circumstances, and there are very few gaps in the Act that need filling. The Act’s definitions are very decisive and leave little room for further interpretation, which is to the public’s benefit because any room left for abuse of the law in this respect might significantly endanger public health and safety. Therefore, in the name of public safety, it is crucial to check that the rules established by the Act are being followed. It’s also commendable that the government is taking the initiative to draft new laws to regulate medical technology.
Author(s) Name: Khushi Agarwal (NMIMS)
References:
[1] THE DRUGS AND COSMETICS ACT, 1940.
[2] The drugs and Cosmetics Rules, 1945.
[3]Drug & Cosmetic Act 1940. CliniExperts. (2020, October 8). https://cliniexperts.com/india-regulatory-bodies/cdsco/drug-and-cosmetic-act-1940_drugs-and-cosmetic-rules-1945_drugs-and-cosmetic-rules-2019/#:~:text=The%20primary%20objective%20of%20the,38%20Sections%20and%202%20schedules> accessed March 26, 2023.
[4] THE DRUGS AND COSMETICS ACT, 1940, S 3.
[5] THE DRUGS AND COSMETICS ACT, 1940 s 3(b)
[6] THE DRUGS AND COSMETICS ACT, 1940, s 3(aaa)
[7] THE DRUGS AND COSMETICS ACT, 1940 s 3(a).
[8] THE DRUGS AND COSMETICS ACT, 1940 s 3(h)
[9] THE DRUGS AND COSMETICS RULES, 1945 s 21(b)
9 Department of Financial Services: Ministry of Finance: Government of India. Department of Financial Services | Ministry of Finance | Government of India. (n.d.). https://financialservices.gov.in/insurance-divisions/Insurance-Regulatory-&-Development-Authority> accessed March 26, 2023
[11] THE DRUGS AND COSMETICS RULES, 1945 Rule 67(G)
[12] THE DRUGS AND COSMETICS RULES, 1945 Rule 97
[13] DTAB-DCC. (n.d.). https://cdsco.gov.in/opencms/opencms/en/dcc-dtab-committee> accessed March 26, 2023
