The Drugs and Cosmetics Act, 1940 governs drug regulation in India, and it has been the subject of policy reform attempts in India from the Mashelakar Committee Report in 2013, up to the most current report of Ranjit Roy Choudhary in 2013. Nonetheless, the regulatory structure continues to be beset by various structural obstacles, including those relating to regulatory harmonization between the center and the states, as well as transparency, which has hampered the regulatory system's overall efficacy. CDL is an abbreviation for Central Drug Laboratory, which was created in Calcutta and is overseen by a director nominated by the Central Government. The Central Drug Control Standard Organization (CDSCO) is primarily involved with policy and the creation of laws and regulations. It is responsible for licensing work such as the approval of licenses for the manufacture of Large Volume Parenteral, Vaccine & Sera, Blood Bank and Blood Components, Medical devices and products manufactured using Recombinant technology, new drug clearance, clinical trials, import registration, drug importation, and inspections.
The drug is Humanity's most powerful weapon in the battle against disease and death. As a result, drugs are the sole commodity that cannot be compromised for any reason. As a result, the requirement for an effective Pharmaceuticals Control Administration to oversee the quality and availability of drugs at reasonable prices is critical. The Government of India established the "Medicines Act" in 1940 to govern the import, manufacturing, distribution, and sale of drugs, and the Governor-General was appointed on April 10, 1940. The Drugs Rules were drafted in 1945 to give effect to the Act's provisions. Cosmetics were added in the jurisdiction of enforcement in 1962, and the Act was renamed "The Drugs and Cosmetics Act" from then on. As a federal nation, India's regulatory competence for drug regulation is shared between the center and the states. The study of the administrative structure and operation of drug regulatory authorities at the central and state levels in India, with a focus on the operation of the Central Drugs Standard Control Organization (CDSCO), national-level regulators, and State Drug Regulatory Authorities (SDRAs) in India, as governed by the Drugs and Cosmetics Act, 1940. Examining the magnitude and scope of regulatory difficulties confronting India's administrative systems and state drug regulatory bodies.
Administration of the Drugs and Cosmetics Act, 1940
A) Advisory :
1) Drugs Technical Advisory Board-DTAB
2) Drugs Consultative Committee-D.C.C.
B) Analytical :
1) Central Drugs Laboratory - CDL
2) Drug Control Laboratory in states
3) Government Analysts
C) Executives :
1) Licensing authorities
2) Controlling authorities
3) Drug Inspectors
Functions of the Drugs and Cosmetics Act, 1940
Analysis or testing of drug/cosmetic samples supplied by customs collectors or judges.
Analytical quality control of imported samples.
Internal standards collection, storage, and dissemination
The creation and maintenance of reference standards.
Microbial culture preservation.
Any further responsibilities delegated by the Central Government.
In the event of a disagreement, acting as an appellate authority.
Objectives of the Drugs and Cosmetics Act, 1940
Licensing is used to govern the import, manufacturing, distribution, and sale of pharmaceuticals and cosmetics.
Only qualified individuals may manufacture, distribute, and sell pharmaceuticals and cosmetics.
To avoid inferior medications.
To control the production and distribution of Ayurvedic, Siddha, and Unani medications.
To establish a Medications Technical Advisory Board (DTAB) and Drugs Consultative Committees (DCC) for allopathic and allied drugs, as well as cosmetics.
Salient features of the Drugs and Cosmetics Act, 1940
The Department of Pharmaceuticals has issued the National Pharmaceutical Pricing Policy-2012, which governs and regulates the pricing of the National List of Essential Medicines-2011. The goal is to establish a regulatory framework for drug pricing in order to ensure the availability of essential medicines at reasonable prices while also providing sufficient opportunity for innovation and competition to support industry growth, thereby meeting the goals of employment and shared economic well-being for all.
According to the Mashelkar Committee's recommendations, the Pharmaceuticals and Cosmetics Act, 1940 was changed by the Drugs and Cosmetics (Amendment) Act, 2008 to strengthen the penalties under the Drugs and Cosmetics Act, 1940 in order to assist combat the issue of fake and contaminated drugs. The following are the key characteristics of the revised sections of the Drugs and Cosmetics Act of 1940:
a) Life imprisonment and a fine of Rs. 10 lakhs or three times the value of the seized items, whichever is greater.
b) Some of the offenses are cognizable and non-bailable;
c) Other gazette officers, in addition to officers from the Drug Controller TMs Office, are authorized to initiate prosecution under the Act;
d) Specially designated courts for the trial of offenses covered by the Act, and
e) Provision for the compounding of minor offenses.
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