13. GOOD REGULATORY PRACTICES

GOOD REGULATORY PRACTICES (GRP)

Good Regulatory Practices (GRP) are processes, systems, tools, and methods for improving the quality of regulations that are internationally recognised. Before government initiatives are implemented, GRP systematically implements public consultation and stakeholder involvement, as well as impact analysis of government proposals to ensure they are fit for purpose and will achieve the goals set out.

OBJECTIVES OF GRP

1. Protecting Public Health and Safety: Ensuring that goods and services adhere to safety and efficacy requirements.
2. Promoting Innovation: Encouraging the creation and acceptance of new goods, services, and technology that advance society.
3. Encouraging Trade: Aligning regulations and standards to facilitate global transport of products and services.
4. Improving Market Access: Simplifying regulatory procedures to help businesses have better market access.
5. Ensuring Reliability and Quality: Creating and enforcing standards to guarantee reliability and quality of goods and services.

COMPONENTS OF GRP

1. Legislative Authority: Regulations should be supported by clear legislative authority.
2. Accountability: There should be an appropriate scheme of accountability in place.
3. Fairness and Openness: Procedures should be fair, accessible, and open.
4. Expertise: Regulators should act with sufficient expertise.
5. Efficiency: The action or regime should be efficient and serve the intended purpose.
6. Evidence-Based Approach: Regulators should take an evidence and risk-based approach to their activities.
7. Risk Assessment and Management: Appropriate risk assessment, management, and communication strategies should be applied.
8. Transparency and Engagement: There should be transparency and opportunities for engagement with stakeholders.
9. Regulatory Impact Assessment: Integrate tools for impact assessment of new and existing regulations.
10. Systematic Monitoring: There should be systematic monitoring and reviews of regulatory performance to ensure regulations are up-to-date and effective.
11. International Standards: Consideration of relevant international standards and frameworks for cooperation.

GRP IN COMMUNITY AND HOSPITAL PHARMACY

Documentation for Drug Sales License

• Affidavit attested by Public Notary (proprietor/partners/authorised person)
• Copy of partnership deed (if partnership firm)
• Address proof of authorised proprietor/applicant (voter ID, driving license)
• Affidavit of liable person for day-to-day working and drug law violations
• Pharmacist Documents: Affidavit, educational qualification certificates, registration certificate from State Pharmacy Council, 2 photographs, address proof, appointment letter and joining letter
• Qualified Person Documents (Wholesale): Educational certificates, experience certificate on affidavit, 2 photographs, appointment/joining letter, 3 copies of premises plan
• Documentary proof of rental/ownership of premises (rental agreement/ownership proof from landlord)

License Fees

Type of Sales License	Fees
Wholesale License	₹1,500 + ₹1,500 = ₹3,000
Retail License	₹1,500 + ₹1,500 = ₹3,000
Restricted License	₹500 + ₹500 = ₹1,000
Schedule-X (Wholesale)	₹500
Schedule-X (Retail)	₹500

Renewals

• Renewal application on same form as new license with necessary fee (same as grant fee)
• Late fee applicable up to six months
• Documents Required: Copy of last renewal, Affidavit of Pharmacist and current rent agreement, Address proof, Affidavit of liable person

GRP IN PHARMA MANUFACTURING

Documentation Required

• Manufacturing licenses
• Product master records
• Batch Manufacturing Records (BMR)
• Materials/component control records
• Personnel records (Adequate Staff)
• Adequate testing facility
• Equipment log books
• Cleaning log books
• Distribution records for every batch (batch number, production and supply quantities, supply date, client information)
• Record of returns, product recalls, and customer complaints

Types of Manufacturing Licenses

Category	Form
Drugs other than Schedules C, C₁, and X	Form 24
Homeopathic Medicines	Form 24C
Schedule X drugs (not specified in Schedules C & C₁)	Form 24F
Schedules C and C₁ drugs (excluding Schedule X)	Form 27
Loan license for Schedules C and C₁ (excluding Schedule X)	Form 27A
Schedules C, C₁, and X drugs	Form 27B
Drugs for examination, test, or analysis	Form 30

Renewals

Manufacturing licenses are valid as long as the licensee deposits the required license retention fee before the end of the five-year period following the date of issuance. If the licensee fails to pay the license retention fee and a late fee, the license will be considered canceled.

GRP IN WHOLESALE BUSINESS

Documents Required for New Licence

• Application (in duplicate) on Form 19 (one for biological drugs, one for non-biological drugs)
• Fee of ₹1,500 per licence (total ₹3,000) deposited in SBI/Government Treasury
• Qualified Person Documents: Attested copy of D.Pharm, registration certificate from State Pharmacy Council, matriculation certificate, affidavit (if employee)
• Affidavit on non-judicial stamp paper (proprietor/partners)
• Map of retail drug store signed by proprietor/partners
• Rent receipt (rented premises) or affidavit (owner premises)

Types of Licenses

• General Licenses (Form 20): For retail sale of drugs other than those specified in Schedule C, C₁, and X.
• Restricted Licenses (Form 20A/21A): For restricted sale of drugs other than Schedule C, C₁, X (20A) and Schedule C, C₁ excluding X (21A).

IMPORT AND EXPORT OF DRUGS AND MEDICAL DEVICES

Documents and Licenses for Import of Drugs

• Registration Certificate (Form 41): Confirms imported drugs meet regulatory standards.
• Import License (Form 10/Form 10A): Form 10 for general/OTC drugs; Form 10-A for Schedule X drugs (renewed every 3 years).
• Covering letter with application
• Copy of Import Permission for New Drug (Form 45 or 45A)
• Drug License (Form 20B/21B)
• Company’s Authorisation Letter (if filed by representative)

Import of Medical Devices

• Registration Certificate (Form 40): Apply to DCG(I) at CDSCO, New Delhi
• Fees: ₹1,12,500 for premises + ₹75,000 per medical device
• Additional Documents: ISO 13485 certificate, Certificate to Foreign Government/Free Sale Certificate, Undertaking of authenticity
• Importers have 60 days to apply for import and registration
• No import without approval for devices not previously imported
• Devices currently in use can be sold during application process (up to 6 months)

Renewals

• Application to be made 9 months before expiry of registration certificate
• Regulatory documentary compliance: Form 40, POA, GMP/COPP, registration certificate, DMF, license, etc.
• Undertakings regarding adverse reactions, manufacturing process changes, and changes in firm constitution
• Details of drugs imported in last 3 years
• Submission of original RC issued

INSPECTION

Inspection of Premises Licensed for Sale of Drugs

• Inspect all premises licensed for sale of drugs at least twice a year
• Obtain and send drug samples for analysis
• Investigate written complaints
• Enter and search places, vessels, vehicles, or persons where offence is believed to be committed
• Order person in possession of illegal drugs not to dispose for up to 20 days, or seize stock if defect cannot be improved

Inspection of Premises Licensed for Manufacture of Drugs and Cosmetics

• Inspect all manufacturing premises at least twice a year
• Inspect plant, process of manufacture, standardising and testing methods, storage methods, location, construction, administration, and technical qualifications of staff
• Obtain samples of manufactured drugs for test/analysis
• Check all records and registers
• Send detailed report of each inspection to controlling authorities

e-GOVERNANCE IN GRP

The Government of India is moving from traditional paper mode to using Information and Communications Technology (ICT) in the governance process – called e-Governance. ICT helps overcome issues like red-tapism, lack of accountability and transparency, lack of access to information, slow movement of files, and ineffective delivery of public services.

Objectives of e-Governance

1. To exchange information with citizens, businesses, or other government departments
2. To provide efficient delivery of public services
3. To enhance internal efficiency of the government system
4. To reduce cost/increase revenue
5. To restructure administrative processes and improve quality of services

Guiding Principles for e-Governance

1. Form Simplification and Field Reduction: Forms should be simplified to capture minimum essential information.
2. Online Applications and Tracking: Online applications with proper tracking mechanism.
3. Online Repositories: For educational certificates, employment documents, etc., to improve citizen convenience.
4. Integration of Services and Platform: Integrated and interoperable services by sharing data between online services and platforms (UIDAI, Mobile Seva platform, etc.).

SUMMARY TABLE: LICENSE FEES AT A GLANCE

License Type	Form	Fees
Wholesale License	–	₹3,000
Retail License	–	₹3,000
Restricted License	Form 20A/21A	₹1,000
Schedule-X (Wholesale/Retail)	–	₹500 each
Manufacturing (General)	Form 24	As prescribed
Import Registration (Medical Devices)	Form 40	₹1,12,500 (premises) + ₹75,000 (per device)