DRUG RECALL LAW OF INDIA
1. Context
Recently Abbot, a multinational pharmaceutical company, published a public notice in newspapers alerting people about a mislabelled batch of the medicine that it had inadvertently shipped to the market. While such recalls take place regularly in the U.S., we have never witnessed domestic or foreign pharmaceutical companies recall substandard or mislabelled drugs in India.
2 Drug recall law in India
- One of the reasons for this difference in behavior in India and the U.S. is that the law in the latter requires pharmaceutical companies to recall from the market those batches of drugs that have failed to meet quality parameters.
- India, on the other hand, has been mulling the creation of a mandatory recall law for substandard drugs since 1976, and yet no law exists that mandates such medicine be removed from the market to this day.
- In 1976, the Drugs Consultative Committee, which consists of all the state drug controllers along with senior bureaucrats from the Ministry of Health and the National drug regulator, the Central Drugs Standard Control Organisation (CDSCO), discussed the issue of drug recalls.
- While the meeting resolved to have greater cooperation between various state drug controllers to facilitate better coordination, this decision never translated into amending the law to create a legally binding structure to enforce such recalls.
- Since then the issue has come up repeatedly in regulatory meetings in 1989, 1996, 1998, 2004, 2007, 2011, 2016, 2018, and 2019 but none of them resulted in amendments to the Drugs and Cosmetics Act to create a mandatory recall mechanism.
- In 2012, certain recall guidelines were published by the CDSCO but they lacked the force of law.
3. Central Drugs standard control organization (CDSCO)
- The Central Drugs Standard Control Organisation (CDSCO) is the National Regulatory Authority (NRA) of India.
- It is under the Directorate General of Health Services, Ministry of Health & Family Welfare.
- Drugs Controller General of India (DCGI) is the head of the department of the Central Drugs Standard Control Organization.
- CDSCO has six zonal offices, four sub-zonal offices, 13 port offices, and seven laboratories.
- CDSCO is the Central Drug Authority for discharging functions assigned to the Central Government under the Drugs and Cosmetics Act.
The functions of CDSCO include
- Approval of new drugs and clinical trials,
- Import registration and licensing of drugs,
- License approving of blood banks, vaccines, and r-DNA products,
- Banning of drugs and cosmetics,
- Grant of test license and personal license for drugs export,
- Testing of new drugs.
4. Why is there no recall law?
- The first is that the Drug Regulation Section of the Union Health Ministry is not up to the task of tackling complex drug regulatory issues due to a combination of factors including apathy, lack of expertise, and a greater interest in enabling the growth of the pharmaceutical industry than protecting public health.
- The second possible factor is India's highly fragmented regulatory structure, with each state having its own drug regulator. But despite the fragmentation, drugs manufactured in one state can seamlessly cross borders to be sold in all states around the country.
- To create an effective recall mechanism, the responsibility of recalling drugs has to be centralized, with one authority wielding the legal power to hold companies liable for failures to recall drugs from across the country.
- However, both the pharmaceutical industry and state drug regulators have resisted greater centralization of regulatory powers.
- The third possible factor is that India's drug regulators are aware of the fact that a mandatory drug recall system, which necessarily has to be centered on a system of wide publicity, will bring to public attention the state of affairs in India's pharmaceutical industry.
5. What happens when substandard drugs are not recalled?
- People, including children, are almost certainly dying or suffering from adverse health events because substandard drugs are not swiftly removed from the market.
- Every month, dozens of drugs fail random testing in government laboratories. Ideally, these drugs will be necessarily recalled transparently, with the people being informed of the failures.
- If this were to happen in India, the people would be flooded with alerts on an almost daily basis, which then would increase the pressure on drug regulators to institute extensive reforms.
6. Issues in Indian drug regulation:
- Spurious and substandard drugs: The country has an inadequate regulatory framework and enforcement regime, reflected in occurrences such as the production of spurious or low-quality drugs. Last year, Indian drug manufacturers received at least 20 letters of warning from the US FDA over the quality of their products.
- Lack of safeguard mechanisms: Lack of adequate mechanisms to safeguard illiterate and vulnerable patients, prevent informed consent violations, and ensure the proper functioning of institutional ethics committees.
- Deficiency in CDSCO: A report commissioned by an Indian parliamentary committee found Central Drugs Standard Control Organisation (CDSCO) struggled with staffing shortages, infrastructure issues, and its responsibilities to ensure public safety. Besides, the Central Drugs Standard Control Organisation does not have the capacity to enforce an actual ban.
- Inadequate drug inspectors: Central and state governments have inadequate numbers of drug inspectors and an overall lack of capacity that leaves them incapable of enforcing recalls and unevenly punishing violators.
- Coordination: Poor communication between state and central drug regulatory bodies compounds the problem. The little-to-no information-sharing between the Centre and the states, and among the states, leads to information asymmetry.
- Poor law implementation: India has among the toughest legislation that allows for life imprisonment if a drug is found to be spurious. But there is weak enforcement of the law, so the number of prosecutions against offenders was low.
7. What are the measures taken for law on drug recall?
- Drugs Consultative Committee (DCC) - In 1976 discussed the issues of recall of bad drugs. The meeting resolved to have greater cooperation between various state drug controllers to facilitate better coordination to recall and destroy drugs that failed tests.
- Parliamentary Standing Committee on Health & Family Welfare - In 2012 raised the issue of recall of drugs but it didn’t materialize.
- Central Drugs Standard Control Organization (CDSCO) - Proposed a set of draft recall guidelines, but the national regulator didn’t convert the guild lines into a binding law.
- Drug Controller General of India (DCGI) - Announced that the guild lines proposed by the CDSCO will be converted into the binding law but it didn’t materialize.
- Drugs Technical Advisory Board (DTAB) - Also discussed the issues concerning the recall of drugs but there was no resolution taken.
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For Prelims: Central Drugs Standard Control Organisation (CDSCO), Drugs Consultative Committee (DCC), Parliamentary Standing Committee on Health & Family Welfare, Drug Controller General of India (DCGI), Drugs Technical Advisory Board (DTAB), and Drugs and Cosmetics Act.
For Mains: 1. What is Central Drugs standard control organization (CDSCO) and explain its functions. Discuss the measures taken for law on drug recall. (250 Words).
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Previous year Question
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1. Which of the following are the reasons for the occurrence of multi-drug resistance in microbial pathogens in India? UPSC 2019)
1. The genetic predisposition of some people
2. Taking incorrect doses of antibiotics to cure diseases
3. Using antibiotics in livestock farming
4. Multiple chronic diseases in some people
Select the correct answer using the code given below.
A. 1 and 2
B. 2 and 3 only
C. 1, 3 and 4
D. 2, 3 and 4
Answer: B
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Source: The Hindu
