REGULATION
OF INDIAN DRUGS – SCI & TECH
News:
Explained | Why are
Indian drugmakers under the lens?
What's
in the news?
●
Since October last year, Indian pharma
companies have been under constant international scrutiny for exporting
allegedly contaminated drugs, which have led to deaths of children.
Key
takeaways:
●
Recently, Nigeria raised the red flag on two oral drugs.
●
Cameroon
too sounded an alarm over another cough syrup reportedly made in India when
several children died.
●
Sri
Lanka called out two drugs manufactured in India linking
them to adverse reactions in several patients.
●
In the latest move, Gambia has declared that from July 1, it is running strict quality
control checks on all pharma products shipped into the country, before they
leave Indian shores.
Has
India launched a probe?
●
Soon after Gambia reported deaths of at
least 70 children related to a contaminated cough syrup made in India, in
December last year, reports from Uzbekistan
of at least 18 children dying after consuming cough syrup contaminated with
high amounts of diethylene glycol (DEG) or ethylene glycol poured in.
●
The pharma company, Marion Biotech’s licence was cancelled by the national watchdog —
the Central Drugs Standard Control Organisation (CDSCO) — in March, but the
Ministry of Health and Family Welfare has not answered any questions on the
probe that was launched.
Drug
Regulations in India:
1.
Central Drugs Standard Control Organization (CDSCO):
●
The CDSCO is the primary regulatory body
in India that regulates the manufacture,
sale, and distribution of drugs in the country.
●
It also conducts periodic inspections of
drug manufacturing facilities to ensure compliance with Good Manufacturing
Practices (GMP) and other regulations.
●
It is responsible for regulating the export of drugs from India.
●
It issues
certificates of pharmaceutical products (CPP) to ensure that drugs exported
from India meet the quality, safety, and efficacy standards of the importing
country.
●
The CDSCO also regulates the labelling,
packaging, and transportation of drugs exported from India.
2.
State-level drug regulatory bodies:
●
At the state level, there exist State Drug
Regulatory Authorities (SDRAs), which are statutory bodies created under the
Drugs and Cosmetics Act, 1940.
●
They fall under the ambit of the
respective Health Departments of each state.
Issues
in Drug Regulations in India:
1.
Quality Control Issues:
●
There have been several instances where
Indian drug manufacturers have been found to be violating quality control
regulations, leading to substandard or
fake drugs in the market.
●
For example, In January (2023), eye drops
manufactured by a Chennai-based pharma company were found to be contaminated
with a deadly drug-resistant bacterium.
2.
Data Manipulation:
●
In 2020, India’s drug regulator found that
a Hyderabad-based pharmaceutical company had submitted manipulated data to get
approval for a drug used to treat bacterial infections.
3.
Non-Compliance with Regulations:
●
Indian drug manufacturers have been
accused of non-compliance with regulations and not following good manufacturing
practices.
●
For example, officials from the Haryana
Food and Drug Administration inspected Maiden’s manufacturing plant at Sonipat
following the WHO alert, they found several discrepancies in the records, due
to which the quality of the raw material could not be ascertained.
4.
Supply Chain Issues:
●
There have been instances of counterfeit drugs and substandard raw
materials entering the supply chain, leading to quality issues in the final
products.
●
For example, according to The US Trade
Representative (USTR) report, nearly 20% of all pharmaceutical goods sold in
the Indian market are counterfeit.
5.
Price Fixing:
●
In 2018, the Competition Commission of
India (CCI) imposed penalties on three pharmaceutical companies for allegedly
fixing the prices of a certain drug.
●
These irregularities have raised concerns
about the safety and efficacy of drugs manufactured in India and highlighted
the need for better regulatory oversight and enforcement.
Challenges
in Indian Drug Regulation Mechanism:
1.
Lack of resources and infrastructure:
●
India has a vast population, and the
country’s drug regulatory system is often overburdened,
with a shortage of staff, laboratories, and equipment.
●
For example, India’s drug regulatory
agency, CDSCO, faces resource constraints such as limited funding, inadequate
staffing, and outdated infrastructure, which can make it difficult to
effectively oversee drug safety and efficacy.
2.
Corruption:
●
Corruption is a significant issue in
India’s drug regulatory system, with reports of officials accepting bribes to
approve drugs.
●
In 2013, the Ranbaxy scandal exposed how
the company had falsified data and received approvals for drugs that did not
meet quality standards.
3.
Price Control:
●
The Indian government regulates the prices
of certain drugs to make them affordable for the general public, which can lead
to conflicts with pharmaceutical companies.
●
For example, in 2013, the Indian
government allowed local companies to produce generic versions of a cancer drug
that was under patent protection, leading to a legal dispute with the drug’s
manufacturer.
4.
Delayed approval process:
●
The approval process for drugs in India
can be lengthy and cumbersome, with approvals taking years to obtain.
●
For example, the approval process for the
vaccine for the COVID-19 pandemic in India took longer than in other countries,
leading to delays in vaccination efforts.
5.
Inadequate monitoring:
●
The lack of a robust system for monitoring
drug safety and efficacy is a significant challenge.
●
This can lead to dangerous drugs being
sold in the market, as was the case with the painkiller Nimesulide, which was
banned in several countries but continued to be sold in India for years.
6.
Poor pharmacovigilance:
●
Pharmacovigilance is the process of monitoring the safety of
medicines once they are on the market.
●
In India, the pharmacovigilance system is
still developing, and there is a lack of awareness among healthcare
professionals and patients about reporting adverse drug reactions (ADRs).
●
For example, there have been reports of
adverse reactions to the COVID-19 vaccine in India, but these have not been
adequately investigated.
7.
Fragmented regulatory framework:
●
India’s regulatory framework is fragmented
between the central government and state governments, leading to varying levels
of quality supervision and providing arbitrage opportunities.
●
This has led to questions about the
sampling methodology used in assessing drug quality.
WAY
FORWARD:
1.
Strengthening the regulatory framework:
●
The government should strengthen the
regulatory framework and enforce stricter laws to ensure that the drugs and
medicines produced in India meet the required safety and quality
standards.
2.
Increasing inspections and audits:
●
Regular inspections and audits should be
conducted at all levels of the pharmaceutical industry to identify and address
any potential issues related to the manufacturing process, quality control, and
distribution.
3.
Enhancing transparency and accountability:
●
The government should promote transparency
and accountability by making the regulatory process more accessible and
understandable to the public and stakeholders.
●
This can be done by improving the
dissemination of information and conducting public consultations.
4.
Providing training and capacity building:
●
The government should invest in training
and capacity building for regulatory agencies and industry professionals to
ensure that they have the necessary skills and knowledge to maintain high
standards of drug quality and safety.
5.
Collaboration with International Bodies:
●
India should collaborate with
international bodies like the World Health Organization (WHO) to adopt best
practices in drug regulation.
●
This will help ensure that Indian
pharmaceutical companies are following global safety and quality standards.
●
The authorities should also work closely
with international bodies to monitor the safety of drugs that are exported from
India to other countries.
6.
Development of a robust pharmacovigilance system:
●
The government can invest in the
development of a robust pharmacovigilance system to monitor adverse drug
reactions and prevent any potential harm to patients.