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Who is responsible for ‘Faulty Formulation in Medicines’?
?? 1. What is Faulty Formulation in Medicines?
this is an important topic in pharmaceutical regulation and public health. Let’s go step by step to clearly understand what faulty formulation means, why it happens, and what responsibilities rest on the Indian pharmaceutical sector and the Central Drugs Standard Control Organisation (CDSCO).
A faulty formulation refers to a defective or substandard pharmaceutical product resulting from errors in the formulation, manufacturing, or quality assurance process.
It means that the composition, quality, or stability of the medicine does not conform to approved standards as defined under Indian law — especially the Drugs and Cosmetics Act, 1940 and the Drugs and Cosmetics Rules, 1945.
?? Types of Faulty Formulation
Type | Description | Example / Consequence |
Substandard Formulation | Active ingredient present in less or more than prescribed quantity | Reduced therapeutic effect or overdose |
Contaminated Product | Presence of microbial, chemical, or particulate impurities | Infection, toxicity, or allergic reaction |
Improper Mixing / Poor Dissolution | Ingredients not uniformly distributed or dissolve poorly | Ineffective drug release in body |
Stability Failure | Product degrades before expiry | Loss of potency or harmful by-products |
Packaging / Labeling Errors | Wrong dosage, misleading info, or misbranding | Medication errors, patient harm |
?? 2. Causes of Faulty Formulation
- Poor Quality Raw Materials (APIs or excipients not meeting pharmacopoeial standards)
- Inadequate Process Control (improper temperature, humidity, or mixing times)
- Negligence or Lack of GMP Compliance
- Insufficient Validation or Testing (skipping stability or bioequivalence studies)
- Counterfeit or Spurious Drug Manufacturing
- Data Manipulation or Non-Transparent Practices
?? 3. Responsibility of the Indian Pharmaceutical Sector
Indian pharmaceutical manufacturers — both domestic and export-oriented — are legally and ethically responsible for ensuring safety, efficacy, and quality at every stage of production.
?? Key Responsibilities
Area | Industry’s Role |
Quality Assurance (QA) and Quality Control (QC) | Establish robust systems to comply with Good Manufacturing Practices (GMP) as per Schedule M of the Drugs & Cosmetics Rules. |
Raw Material Sourcing | Verify authenticity and purity of Active Pharmaceutical Ingredients (APIs). |
Batch Manufacturing Records | Maintain complete traceability of each batch for recall and investigation. |
Stability Studies | Conduct long-term and accelerated studies to ensure shelf life and safety. |
Self-Inspection & Audits | Periodically inspect facilities and correct deficiencies. |
Post-Market Surveillance | Monitor product performance and report adverse events. |
Recalls and Transparency | Promptly recall defective batches and inform regulators and consumers. |
????? 4. Role and Responsibility of CDSCO (Central Drugs Standard Control Organisation)
The CDSCO is India’s national regulatory authority under the Ministry of Health and Family Welfare.
It ensures that drugs, cosmetics, and medical devices marketed in India are safe, effective, and meet quality standards.
?? Key Functions of CDSCO
Function | Description |
Regulatory Approval | Approves new drugs, vaccines, and fixed-dose combinations after scientific evaluation. |
Licensing and GMP Enforcement | Inspects manufacturing facilities (along with state FDAs) to ensure compliance with Schedule M (GMP standards). |
Quality Surveillance | Tests samples from the market via central and state drug testing laboratories. |
Pharmacovigilance (PvPI) | Monitors adverse drug reactions and coordinates recalls of defective medicines. |
Coordination with State Drug Authorities | Supervises implementation of the Drugs and Cosmetics Act at the state level. |
Import Control | Regulates the import of APIs and finished formulations. |
Public Alerts and Recalls | Issues alerts about substandard or falsified drugs through official notifications. |
?? 5. Legal and Regulatory Provisions
Act / Rule | Key Relevance |
Drugs and Cosmetics Act, 1940 | Governs manufacture, sale, and distribution of drugs in India. |
Section 18(a)(i) | Prohibits manufacture or sale of any drug not of standard quality or misbranded. |
Section 27 | Provides penalties, including imprisonment, for producing substandard or adulterated drugs. |
Schedule M (Rules) | Prescribes Good Manufacturing Practices (GMP). |
Schedule U | Specifies record-keeping requirements for batch manufacturing and testing. |
?? 6. Consequences of Faulty Formulation
Stakeholder | Impact |
Patients | Health risk, treatment failure, drug resistance (especially antibiotics). |
Industry | Product recalls, reputational damage, legal action, export bans. |
Public Health | Erosion of trust, potential large-scale health emergencies. |
Economy | Loss of export credibility and foreign market access. |
?? 7. Recent Context and Global Responsibility
India is known as the “Pharmacy of the World”, exporting medicines to over 200 countries.
However, recent incidents — such as contaminated cough syrups linked to child deaths abroad (e.g., in Gambia, Uzbekistan)** — have led to increased global scrutiny.
CDSCO has since:
- Strengthened inspection and testing at manufacturing units.
- Implemented risk-based audits for export-oriented firms.
- Mandated stricter documentation and stability data.
- Enhanced coordination with the WHO and importing country regulators.
? 8. Strengthening Accountability
Measure | Purpose |
Digital Drug Tracking (Track & Trace system) | Prevent spurious drug distribution. |
Stricter Licensing Conditions | Ensure capacity and quality infrastructure. |
Periodic GMP Re-certification | Ongoing compliance verification. |
Transparency in Public Reporting | Publish test results of drug samples. |
Training and Capacity Building | For regulators and manufacturers. |
?? In Summary
Faulty formulation = A medicine that fails to meet approved safety, purity, or potency standards.
Responsibility lies jointly with:
- Pharma companies — to follow GMP and ensure quality at all stages.
- CDSCO and State Drug Authorities — to enforce strict oversight, testing, and regulatory action.
Together, they are legally and morally accountable for ensuring that every medicine reaching patients is safe, effective, and of assured quality.
***