The Indian pharmaceutical industry is recognized globally for its scale, diversity, and contribution to public health. At the same time, it operates under one of the most rigorous regulatory frameworks in the world. This stringent oversight is essential because medicines directly affect human life and public health, and any compromise on quality, safety, or efficacy could have severe consequences.
The legal foundation for regulating pharmaceuticals in India is laid down by the Drugs and Cosmetics Act, 1940 and the Drugs and Cosmetics Rules, 1945. Together, these govern every stage of the drug lifecycle—covering manufacturing, testing, quality assurance, packaging, labeling, sale, and distribution. The primary objective of these laws is to ensure that medicines made available to patients are safe, effective, and of assured quality.
Under this framework, no individual or company can begin the manufacture of drugs without first obtaining a valid license from the appropriate regulatory authority. The type of license required depends on the nature of the drugs being manufactured. One of the most common approvals sought by pharmaceutical manufacturers is the License to Manufacture for Sale or Distribution of Drugs other than those specified in Schedules C, C(1), and X.
This license covers a wide spectrum of allopathic medicines—such as tablets, capsules, syrups, powders, ointments, and creams—that are not classified as:
• Biological or special products (listed under Schedule C & C(1)), including vaccines, sera, toxins, insulin, and parenteral preparations, or
• Narcotic and psychotropic substances (listed under Schedule X), which have a high potential for abuse and therefore require stricter control.
This license applies to allopathic drugs that are not included in the following categories:
• Schedule C & C (1): Biological products and specialized preparations such as vaccines, sera, toxins, insulin, and parenteral drugs.
• Schedule X: Narcotic and psychotropic substances with high potential for abuse, such as certain tranquilizers and hypnotics
Applicants must meet the following prerequisites before filing for the license:
1. Manufacturing Premises
The premises must meet the minimum space, layout, and infrastructure requirements prescribed under the Drugs Rules.
2. Technical Staff
At least one qualified technical staff member must be employed, such as:
A graduate in Pharmacy or Pharmaceutical Chemistry, or
A graduate in Science with adequate experience in drug manufacturing.
3. Plant and Machinery
The manufacturing facility should be equipped with machinery and testing equipment suitable for the intended range of products.
4. Good Manufacturing Practices (GMP)
Compliance with Schedule M (GMP guidelines) is mandatory, covering hygiene, documentation, quality control, and safety protocols.
Step 1: Filing of Application
• Submit the application in Form 24 under the Drugs and Cosmetics Rules, 1945.
• Pay the prescribed government fee.
Step 2: Submission to Licensing Authority
• The application must be filed with the State Licensing Authority (SLA) where the unit is located.
• Details of the premises, equipment, and staff must be furnished.
Step 3: Supporting Documents
Key documents generally required include:
1. Application Cover Note – A formal request submitted to the licensing authority.
2. Authorization Letter – Legal authority permitting a representative to act on behalf of the company.
3. Factory Layout Plan – Detailed building/site plan prepared as per Schedule M norms.
4. Premises Proof – Registered ownership, rental, or lease documents of the facility.
5. Pollution Consent Certificate – Approval from the State Pollution Control Board to establish the unit.
6. Entity Constitution Papers – ROC extract, partnership deed, or trust deed confirming business structure.
7. Qualified Staff List – Names, qualifications, and experience of technical personnel.
8. Appointment Proof – Manufacturing Section – Document confirming employment of technical staff in production.
9. Appointment Proof – Testing Section – Document confirming employment of technical staff in quality/testing.
10. Machinery Inventory – Section-wise list of manufacturing and testing equipment.
11. Industrial Safety NOC – No Objection Certificate from the Department of Safety & Health.
12. HVAC Validation Report – Certificate of installation and performance of HVAC system.
13. Water System Validation Report – Certificate confirming proper installation and validation of the water system.
14. Site Reference File – A master file describing infrastructure and operations of the site.
15. Standard Operating Documents – List of SOPs and STPs implemented in the facility.
16. Declaration by Technical Personnel – Undertaking given by the employed technical staff.
17. Declaration by Directors – Undertaking submitted by company directors.
18. Testing License (Form 29) – Valid license for carrying out testing activities.
19. Bulk Drug Source Records – Supplier details with regulatory approvals (Form 46A/45A/CT-19/CT-22, if required).
20. Raw Material COA – Certificate of Analysis for active substances and excipients.
21. Manufacturing Master Formula – Authorized formulation for the manufacturing process.
22. Production Method Document – Stepwise procedure for drug manufacturing.
23. Product Development File – Report covering compatibility, trials, and stability studies.
24. Validation Study Report – Document validating the consistency of the manufacturing process.
25. Final Product Standards – Specification sheet including impurity details of the finished drug.
26. Final Product Testing Method – Approved procedure for testing finished medicines.
27. Analytical Validation File – Validation details for analytical/testing methods used.
28. Batch COA Records – Certificates of Analysis for three consecutive or validation batches.
29. Stability Data Report – Study results showing stability of drugs under set conditions.
30. Dissolution Profile Data – Comparative release profile for oral dosage forms.
31. Equivalence Evaluation Report – Comparative pharmaceutical equivalence study with market brands.
32. Packaging Specimens – Draft labels and cartons for finished products.
33. Bioequivalence Study Report – Protocols and results of bioequivalence testing.
34. Waiver Request Note – Justification for exemption from bioequivalence studies, if applicable.
35. New Drug Authorization – Approval from Central Licensing Authority for new drug applications.
36. CDSCO Certificate (Form 10) – Issued by CDSCO where specifically required.
37. Undertaking (Form 51) – Applicant’s declaration form.
38. Fee Payment Receipt – Official challan confirming fee payment.
39. Application Form (Form 24) – Prescribed form for applying for the license.
Step 4: Inspection
• The State Licensing Authority conducts a detailed inspection of the premises with assistance from Drug Inspectors.
• The inspection verifies compliance with infrastructure, staffing, and GMP requirements.
Step 5: Grant of License
• If the authority is satisfied, the license is issued in Form 25.
• The license is valid for five years, unless suspended or cancelled earlier.
Holders of the license must adhere to specific conditions, including:
• Maintaining records of manufacturing and distribution.
• Conducting quality control testing for every batch.
• Not manufacturing prohibited or banned drugs.
• Ensuring the continuous employment of qualified staff.
• Displaying the license prominently at the manufacturing site.
• The license remains valid for five years.
• Renewal applications must be submitted before the date of expiry, along with the prescribed fee.
• Failure to renew may lead to suspension or cancellation of the license.
Obtaining this license is essential for pharmaceutical manufacturers as it:
• Ensures Legal Compliance – Prevents penalties and legal action under the Drugs and Cosmetics Act.
• Safeguards Public Health – Guarantees that only quality-assured medicines are manufactured and supplied.
• Facilitates Market Access – Enables manufacturers to legally produce and distribute medicines across India.
The License to Manufacture for Sale or Distribution of Drugs other than those specified in Schedules C, C(1), and X forms the foundation for pharmaceutical manufacturing in India. Compliance with statutory requirements, adherence to GMP, and readiness for inspection are crucial for successfully obtaining the license.
Pharmaceutical entrepreneurs and companies planning to establish manufacturing facilities must carefully prepare their applications, maintain transparency in operations, and strictly comply with regulatory obligations to ensure smooth approval and uninterrupted business operations.
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