The Government of India has issued a crucial directive recently so far as the responsibility of drug marketers in India goes. It follows Risk-Based Inspections (RBI) to maintain compliance with the Drugs & Cosmetics Act, 1940 and allied rules. It emphasizes the point that marketers are equally responsible for drug quality as manufacturers and defines what the state government authorities must do to maintain public health in check.
This action is important to the drug industry, regulators, and consumers alike because it requires stringent compliance with Good Manufacturing Practices (GMP) and regulation.
Background: Risk-Based Inspections in India
The CDSCO has been conducting Risk-Based Inspections (RBI) on a national basis to verify if the drug manufacturing facilities are compliant or not. The inspections are conducted in a risk-based fashion and special emphasis is placed on the manufacturers that have the capability to pose more risk to human health.
- RBIs give a means of measurement of compliance in terms of Drugs & Cosmetics Act, 1940, and Rules thereunder.
- These inspections are market data meaning, scanning for inspection units and marketers.
- It is an aim to offer drug quality, efficacy, and safety in the Indian marketplace.
By pursuing the manufacturers and marketers of risky producers, the authorities are using the preventive approach rather than responding to deficiencies. The aim is to mitigate risks to consumers.
Findings of Recent Observations
The findings on observations during the inspections were as follows salient findings:
- A number of serious offenses were observed by inspection teams.
Such facts have driven SLA to certain steps like:
- Stop Manufacturing Activity Orders
- Cancellation of manufacturing portions
- Suspension of product approvals
- Warning letters
These facts clearly show the seriousness with which the government is addressing the non-compliance in the drug manufacturing sector. Notably, it was observed that the majority of significant non-compliance was brought in by associated manufacturers and marketers.
Obligations Under Rule 84(E)
The marketers have to execute and get their name enrolled on the register.
One of the issues which are squarely addressed in the directive is Rule 84(E) of the Drug Rules 1945, viz.:
- The responsibility for drug quality and regulatory compliance lies with the marketer as well as the manufacturer.
- The rule stipulates that marketers are neither sellers nor distributors; they assume legal and
moral responsibility for:
- Maintaining drug quality sold
- Making producers conform to GMP norms
- Compliance with regulatory standards according to CDSCO guidelines
Technically, if a producer is non-conforming to GMP or makes defective drugs, then the responsible marketer is to be held accountable as well.
Individual Cases Identified
The order cites two important cases:
- Gujarat: State Drug Controllers have been instructed to take action against marketers associated with non-conforming producers.
- Delhi: Similar strategy is also being adopted here where marketers are being held liable.
Additionally, inspection reports showed that in some instances, addresses listed on the label of medicines were discovered to be nonexistent, pointing towards misrepresentation on the part of the marketer.
Implications for the Pharmaceutical Industry
The directive has significant implications for Indian marketers and producers:
Greater Responsibility: Marketers can no longer plead ignorance about production processes; they are accountable.
Legal Liability: Failure on the part of the marketer invokes regulatory action in terms of warning, suspension, or judicial proceedings.
Public Health Emphasis: Adherence by itself of high-quality drugs to be available for sale is good for consumer protection.
Increased Enforcement: The state governments have now been empowered to take action against marketers directly and thus provide a two-layer responsibility.
Action to be Taken by the State Authorities
- State/UT Drugs Controllers are mandated to:
- Sensitize marketers in their own states regarding their legal compliances.
- Take appropriate action against erring marketers.
- Facilitate effective implementation of the Drug Rules 1945.
- Report whatever action taken to the CDSCO headquarters forthwith.
This order has been prioritized, and urgency has been emphasized in compliance and monitoring.
Why This Directive Is Important
The importance of this CDSCO order cannot be overemphasized. It highlights a few critical points:
Quality maintenance of drugs
Low-quality medicines have extreme health consequences, ranging from failure of treatment to drug resistance and side effects. By holding marketers accountable, authorities make sure that all players come under high standards.
Sealing Loops in the Supply Chain
In the past, manufacturers carried the burden. Marketers also managed to escape even when they sold non-compliant manufacturers’ products. The directive closes that loop, putting everyone in overall compliance.
Increasing Public Health
Lastly, the goal is to protect public health. RBI and regulation both are intended to keep low-quality or misbranded drugs out of the patients’ hands.
Encouraging Transparency
By requiring accurate addresses and label information, the directive encourages transparency and traceability of the supply chain of the drug.
What Marketers Must Do
- Marketers must themselves ensure compliance with these directives:
- Ensure GMP of manufacturers prior to marketing products.
- Confirm and verify label information, such as addresses, for authenticity.
- Keep records of compliance audits and quality checks.
- Inform personnel of their role under Rule 84(E).
- Non-compliance in distribution would be notified to regulatory authorities.
Legal action, suspension, or warning by state regulators would ensue due to non-compliance.
CDSCO’s Role in Maintaining Assurance for Compliance
- The Central Drugs Standard Control Organization is at the center of this activity:
- Conducts Risk-Based Inspections nationwide.
- Leads and supports state regulators.
- Monitors action taken against defaulting marketers and manufacturers.
- Ensures regulatory enforcement is in the public health interest.
CDSCO‘s aggressive posture is in line with its mission to foster high quality drug standards in India.
Conclusion
The new pattern trailed by the most recent directive of the Drugs Controller General of India is a seismic pattern of enforcement: the marketers officially are on the line for drug quality and compliance by drugs they market.
Points to remember:
- The manufacturers as well as marketers are on the line for drug quality.
- The state governments have been instructed to take swift action against wayward marketers.
- This program enforces public health safeguards in terms of safe, efficient, and consistent medicines supplied in the marketplace.
- GMP compliance and correct label information can’t be bargained with by anyone.
- It is the age of responsibility and caution for the pharma industry, with compliance, quality, and public safety as the pillars.
Important Points from CDSCO Directive
- Risk-Based Inspections (RBI) are conducted to inspect compliance.
- Critical observations on inspections have led to stop manufacturing, cancellation of part or entire production, suspension of product authorizations, and warning.
- Rule 84(E) prescribes that marketers are jointly and severally responsible for drug quality and compliance.
- Delhi and Gujarat State Drugs Controllers have been clearly instructed to initiate action against defaulting marketers.
- Almost no packs of drugs had non-existent addresses, and that is a naked example of misrepresentation.
- The marketers are required to offer GMP compliance, labeling, and documentation.
- CDSCO monitors public health and safety measures.