Lack of Drug Recall Law in India
Context:
- Due to lax regulatory standards and a lack of a law requiring the recall of medications, the number of defective drugs is increasing in India.
The control of drugs in India:
- The $42 billion pharmaceutical market in India ranks third internationally in terms of volume.
- A pharmaceutical business must obtain DCGI (Drug Controller General of India) approval before marketing a brand-new prescription drug in India.
- The Central Drugs Standard Control Organisation (CDSCO) in India is led by the drug controller general of India (DCGI). The country’s pharmaceutical regulating system is overseen by DCGI.
- The Central Drug Authority for carrying out duties delegated to the Central Government under the Drugs and Cosmetics Act is the Central Drugs Standard Control Organisation (CDSCO).
- According to the Drug and Cosmetics Act (DCA), State authorities are largely in charge of regulating the production, marketing, and distribution of drugs, while Central Authorities are in charge of approving new drugs.
Regulation’s difficulties:
- Fragmented regulatory framework – Since each state in India has its own drug regulators and there are 38 in all, a medicine that is prohibited in one state may nonetheless be sold in another.
- Issues with jurisdiction – The presence of numerous regulators has resulted in uneven application of the law.
- Lack of emphasis on processes – The Indian system is still focused on final goods rather than processes (medicines sold on the market).
- Absence of openness – The law has no provisions requiring the disclosure of medical requirements or requiring transparency.
- Drug regulation is complicated, making it challenging to regulate, according to the union health ministry’s drug control section.
- Lack of knowledge at the union health ministry’s drug relation branch.
- Pharmaceutical industry over public health protection – The government is more interested in promoting the expansion of the pharmaceutical industry than in safeguarding the general population’s health.
- There is no binding law on drug recall, despite the fact that the government has been considering one since 1976. Instead, there are guidelines for drug recall.
Suggestions:
- Change the pharmaceuticals and Cosmetics Act: The Drugs and Cosmetics Act’s main objective is to prevent the sale of substandard pharmaceuticals rather than to react to them after the fact. Therefore, the DCA must be changed to stop the production of inferior pharmaceuticals in the first place.
- Establish a stringent quality control system: Manufacturers should implement good manufacturing practises. Simple checks and balances must be followed, such as checking raw materials before incorporating them into drugs, purchasing raw materials from authorised producers, keeping equipment clean, etc.
- Coordination and uniformity across several departments: Each state has its own regulations for handling cases. A system should be set up so that regulators may communicate effectively with one another. A set of uniform guidelines should be followed as well.
- Address the structural problems with drug regulation by giving the employees the necessary training. Additionally, the positions should be filled immediately away to prevent overwork.
Moving ahead:
- Due to India’s strong foundation in pharmaceutical third-party manufacture and the perseverance demonstrated particularly during the epidemic, it is clear that the country’s pharmaceutical sector contains significant power and development potential. India can effectively utilise its gifted human resource to expand on a worldwide scale with the aid of careful policy development, quality assurance, and an efficient drug regulations framework.
