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According to many analyses by legal and health experts, the Drugs and Cosmetics Act,1940 is not going to deliver rational, reliable, and effective regulation of drugs. After many amendments, the 2013 Drugs and Cosmetics Act was the latest rectification made in this bill.
What are the drug and cosmetic acts?
The Drugs and Cosmetics Act was created by the Parliament of India. It is made to control the import, production, and delivery of drugs throughout the nation. This act makes sure that drugs and cosmetics used in India are reliable and efficient to use. It also makes sure that the production of these drugs and cosmetics adheres to the rules made for them.
The Cosmetic in the act refers to any substance that is meant to be applied to the human body for the objective of beautifying and cleansing. The drug refers to the huge variety of substance, diagnostic, and medical devices. This act was later amended as the Drugs (amendment) Act 1964 to include Unani and Ayurvedic Drugs.
The rules within this act have been amended several times to include or exclude anything mentioned. It was done to meet the needs of the citizens and to keep up with the global changes.
What Is CDSCO?
The Central Drugs Standard Control Organization is India’s national regulatory body for pharmaceuticals and medical devices. Its headquarter is located in Delhi. In India, all the major risks are divided into “risk classes” A to D. ‘A’ stands to be in the lowest risk category, and D being the highest. The work of CDSCO is to inspect and approve them accordingly. There are 11 medical devices and equipment certified by CDSCO, as of January 1, 2020.
Why Is It Important To Introduce A New Drugs Act?
The nation’s drug regulation system is meeting serious problems. The policymakers are fighting to find the best way to introduce these problems. Major concerns of this problem are- bad regulatory infrastructure and sick performance, absence of safe and effective medicines, poorly managed clinical trials, and increased fixed-dose combinations (FDC’s). It is the reason for scrutiny and controversy in the public sphere and academics. Whenever the nation tries to catch up with the global regulatory acts, it finds itself stuck in the sphere of criticism.
As a matter of fact, all these regulations need the support of the legislation. A true effective regulation would not happen with legislators supporting the introduction of new drug laws. It is necessary for India’s major contribution to global drug manufacture. Such an Act should have drafted rules requiring accurate and transparent evidence that supports the effectiveness and safety of new drugs in the context of public need.
Rejections by the Parliamentary Committee
The latest attempt to deal with the concern of drugs was the Drugs and Cosmetics (Amendment) Bill introduced by the Indian Parliament in August 2013. In 2014, two key proposals were created- the creation of higher authority than CDSCO and an extension of the regulatory system to cover exported medicines. These proposals were rejected by the parliamentary committee.
Multiple conclusions stand out when we talk about drug laws. The prevailing Drugs and Cosmetics Act we have is pretty much old and imperfect. The core of this law was passed under British rule in 1940. Although it was amended 10 times after that, it holds no duty on the regulator. Therefore, it does not ensure the safety and effectiveness of the drug before it is sold. The latest amendment done to this act was in 2013, which continues the confusion between the concepts of effectiveness and efficacy. Efficacy is defined as the intervention that produces a beneficial result. Effectiveness is defined as the extent to which a specific intervention does what is intended to be done. When a drug has to be effective for use, India’s drug rules have high standards for the same.
Another problem is with increased central control of drug regulation. The central government is responsible for imported drugs, whereas the state government is responsible for the manufacture, distribution, and sale. This distribution of power is not the same anymore. The central government has more authority over drugs than the state government. The two amendments to this act, made in the year 1982 and 2008, gave the central government more power to regulate, restrict, or prevent drugs on definite grounds in the public interest.
The last twisted concept of the law is that it allows the central regulator the power to judge or act in ways that are not subject to transparency and accountability mechanisms. CDSCO is supposed to make rules or regulations for the supply, manufacture, and marketing of drugs and cosmetics, they are not obliged to explain the discretion made by them. The 2013 edition of the bill has done nothing to address this indiscretion.