13. GOOD REGULATORY PRACTICES (GRP)

GOOD REGULATORY PRACTICES: A TEACHER’S COMPREHENSIVE GUIDE

Welcome, future pharmacists and healthcare professionals!

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.

As a pharmacy educator with years of experience teaching Pharmaceutical Jurisprudence and Regulatory Affairs, I have observed that students often find regulatory practices complex and theoretical. However, understanding Good Regulatory Practices is essential for every pharmacist—they form the foundation of how pharmaceutical regulations are developed, implemented, and enforced in India. In this comprehensive guide, I will break down GRP into manageable sections, explaining the objectives, components, and their application in community pharmacy, hospital pharmacy, manufacturing, wholesale business, import/export, inspection, and e-governance. Let us begin our journey.

Dpharmguru’s exam insights:

Good Regulatory Practices are frequently tested in pharmacy law and regulatory affairs exams. Remember: GRP involves public consultation, impact analysis, and evidence-based approaches. The components include legislative authority, accountability, fairness, expertise, efficiency, evidence-based approach, risk assessment, transparency, regulatory impact assessment, systematic monitoring, and international standards. Pay special attention to the documentation requirements for various licenses—these are almost always asked in exams!

OBJECTIVES OF GRP

The objectives of Good Regulatory Practices are as follows:

• Protecting Public Health and Safety: Making sure that goods and services adhere to safety and efficacy requirements in order to safeguard users and the environment.
• Promoting Innovation: Encouraging the creation and acceptance of new goods, services, and technology that advance society.
• Encouraging Trade: Aligning regulations and standards to make it easier for products and services to be transported globally.
• Improving Market Access: Simplifying regulatory procedures to help companies have better access to the market.
• Ensuring Reliability and Quality: Creating and enforcing standards to guarantee the reliability and quality of goods and services.

Dpharmguru’s exam insights:

The five objectives of GRP are frequently tested. Remember them as: (1) Protecting Public Health and Safety, (2) Promoting Innovation, (3) Encouraging Trade, (4) Improving Market Access, (5) Ensuring Reliability and Quality. This is a common long-answer question in exams!

COMPONENTS OF GRP

Good Regulatory Practices are essential for ensuring that regulations are efficient, effective, and serve the public interest. Here are the key components of GRPs:

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

Dpharmguru’s exam insights:

The eleven components of GRP are frequently tested. Remember the key ones: Legislative Authority, Accountability, Fairness and Openness, Expertise, Efficiency, Evidence-Based Approach, Risk Assessment, Transparency, Regulatory Impact Assessment, Systematic Monitoring, and International Standards. These ensure that regulations are effective and serve the public interest!

GRP IN COMMUNITY AND HOSPITAL PHARMACY

A. Documentation Required for Drug Sales License

The following documents are prerequisites for the application of a Drug Sales License:

• Affidavit attested by Public Notary:
• Of Proprietor (if proprietorship firm).
• Of all partners (if partnership firm).
• Of the person duly authorised by the Board of Directors (if Private Limited or Limited Company).

• Copy of partnership deed (if partnership firm).
• Address proof of the authorised proprietor/applicant (voter ID, driving license).
• Affidavit of the liable person for day-to-day working and for any violation of laws pertaining to Drugs.
• Documents related to Pharmacist:
• Affidavit duly attested by Public Notary.
• Copies of educational qualification certificates (Attested).
• Attested copy of registration certificate and its renewal issued by State Pharmacy Council.
• Two photographs per applied license.
• Address proof.
• Appointment letter and joining letter.

• Documents related to qualified person (for Wholesale license):
• Attested copies of educational qualification certificates.
• Experience certificate on the affidavit.
• Two photographs per applied license.
• Appointment letter and Joining letter (if applicable).

• Documentary proof of rental or ownership basis:
• Photocopy of the rental agreement (in case of rented premises).
• Attested copy of ownership proof of rented premises from the landlord.

B. Licenses and Fees

While applying offline, the fees should be paid in the Government Treasury or Government Branch of State Bank of India of the district where the license is required. The original treasury challan must be submitted with the application.

C. Renewals

Renewal of a Sale license should be made on the application form same as the form submitted during the grant of the new license along with the necessary fee. The Fee for the renewal of the license is same as the grant of license. The late fee for the renewal of the license is applicable up to six months.

Documents Required for Renewal:

• Copy of last renewal.
• Affidavit of Pharmacist and current rent agreement.
• Address proof of the authorised proprietor/applicant.
• Affidavit of the liable person for day-to-day working and for any violation of drug laws.

Dpharmguru’s exam insights:

Documentation and licensing requirements are frequently tested. Remember: Wholesale and Retail licenses cost Rs. 3000 each; Restricted licenses cost Rs. 1000; Schedule-X licenses cost Rs. 500; renewal requires the same form and fee; late fee is applicable up to six months. The documentation requirements for pharmacists and qualified persons are also important!

GRP IN PHARMA MANUFACTURING

A. Documentation

The following records need to be kept up to date in pharmaceutical manufacture per GRP:

• 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 of the product (batch number, production and supply quantities, supply date, and client information).
• Record of returns, product recalls, and customer complaints.

B. Licenses

C. Renewals

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

Dpharmguru’s exam insights:

Manufacturing documentation and licenses are frequently tested. Remember: BMR records must be maintained; distribution records for every batch are required; Form 24 is for drugs other than Schedule C, C1, X; Form 27 is for Schedule C and C1 drugs; Form 27B is for Schedule C, C1, and X drugs; licenses are valid for 5 years with retention fee.

GRP IN WHOLESALE BUSINESS

A. Documentation

A licence is required to sell, stock, exhibit for sale, or distribute drugs. To open a retail drug store, the following documents are needed:

• Application (in duplicate) on Form 19 of the Drugs and Cosmetics Rules, 1945 (one for biological drugs, one for non-biological drugs).
• A fee of Rs.1500 per licence (total Rs.3000) for grant of a retail sale licence.
• Attested copy of Diploma in Pharmacy.
• Attested copy of registration certificate issued by State Pharmacy Council.
• Attested copy of matriculation certificate.
• Affidavit from the qualified person (if employee).
• Affidavit on non-judicial stamp paper by each partner or proprietor.
• Map of the retail drug store signed by proprietor/partners.
• Rent receipt or affidavit of ownership.

B. Licenses

• General Licenses (Form 20): Granted to an individual having premises for the business with a qualified person to supervise the sale of a drug store.
• Restricted Licenses (Form 20A and 21A): Granted for the restricted sale of drugs other than those specified in Schedule C, C1, and X.

C. Renewals

As of right now, there is no renewal system. If a licensee pays a prescribed license retention fee before the next five years from the date of issuance, the license will stay valid. The license will be considered canceled if the licensee does not pay the license retention fee and late fees by the deadline.

Dpharmguru’s exam insights:

Wholesale documentation is frequently tested. Remember: Form 19 is used for retail licence application; Form 20 is for general retail license; Form 20A is for restricted license; fees are Rs.1500 per licence; retention fees must be paid every 5 years. The documentation requirements are extensive—including educational certificates, affidavits, and property documents!

IMPORT AND EXPORT OF DRUGS AND MEDICAL DEVICES

In the field of the pharmaceutical industry, India is ranked 3rd in the world. India has opened its pharmaceutical market to MNCs and supports the import and export of drugs throughout the country.

A. Documents and Licenses for Import of Drugs

• Registration Certificate (Form 41): Obtain a registration certificate for the import of drugs for commercial use.
• Import License (Form 10/Form 10A):
• Form 10 for general and OTC drugs.
• Form 10-A for Schedule X drugs.
• Licenses must be renewed every three 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 someone else submits the file).

B. Documents and Licenses for Import of Medical Devices

• Registration Certificate (Form 40): Application for Registration Certificate for premises and devices intended for import.
• Registration Fee: 1,12,500 INR for premises + 75,000 INR for each individual medical device.
• Required Documents: ISO 13485 certificate, Certificate to Foreign Government or Free Sale Certificate, and an undertaking.

C. Renewals

The application is to be made 9 months before the expiry of the registration certificate, along with regulatory documentary compliance like Form 40, POA, GMP/COPP, registration certificate, DMF, license, etc.

Dpharmguru’s exam insights:

Import/export documentation is frequently tested. Remember: India is the 3rd largest pharmaceutical market; Form 10 for general import, Form 10-A for Schedule X; Form 41 for registration; Form 40 for medical devices; import licenses are renewed every 3 years; renewal application must be made 9 months before expiry.

INSPECTION

A. Inspection of Premises Licensed for Sale of Drugs

• Inspect all premises licensed for the sale of drugs at least twice a year.
• Obtain and send drug samples for analysis.
• Investigate any written complaints.
• Enter and search places where an offence is believed to be committed.
• Order persons in possession of illegal drugs not to dispose of them for not more than 20 days or seize the stock.

B. Inspection of Premises Licensed for Manufacture

• Inspect all premises licensed for the manufacture of drugs not less than twice a year.
• Inspect plant, process of manufacture, means employed for standardising and testing drugs, methods and places of storage.
• Obtain samples of drugs manufactured and send them for test or analysis.
• Check all records and registers.
• Send detailed report of each inspection to the controlling authorities.

Dpharmguru’s exam insights:

Inspection requirements are frequently tested. Remember: Sale premises must be inspected at least twice a year; manufacturing premises also at least twice a year; samples must be obtained and sent for analysis; inspectors can order not to dispose of illegal drugs for up to 20 days; detailed reports must be submitted.

E-GOVERNANCE IN GRP

The Government of India is transitioning from traditional paper mode to using Information and Communications Technology (ICT) in the governance process. The use of ICT in the governance process is called e-Governance.

A. Objectives of E-Governance

• To exchange information with citizens, businesses, or other government departments.
• To provide efficient delivery of public services.
• To enhance internal efficiency of the government system.
• To reduce cost or increase revenue.
• To re-structure administrative processes and improve quality of services.

B. Guiding Principles for E-Governance

• Form Simplification and Field Reduction: Forms should be simplified and structured to capture minimum essential information.
• Online Applications and Tracking: Online applications with proper tracking mechanisms should be developed.
• Online Repositories: Online repositories (e.g., for educational certificates, employment documents) should be used.
• Integration of Services and Platform: Integrated and interoperable services should be provided by mandating data sharing between online services and platforms like UIDAI, Mobile Seva platform, etc.

Dpharmguru’s exam insights::

E-Governance is frequently tested. Remember: It uses ICT for governance; objectives include efficient service delivery, cost reduction, and quality improvement; guiding principles include form simplification, online applications, online repositories, and integration of services. UIDAI and Mobile Seva are key platforms!

COMPARISON: GRP COMPONENTS

FREQUENTLY ASKED QUESTIONS (FAQs)

1. What is Good Regulatory Practice (GRP)?

GRP refers to processes, systems, tools, and methods for improving the quality of regulations. It includes public consultation, stakeholder involvement, and impact analysis of government proposals.

2. What are the objectives of GRP?

The objectives are: protecting public health and safety, promoting innovation, encouraging trade, improving market access, and ensuring reliability and quality.

3. What documents are required for a retail drug sale license?

Documents include: affidavit, partnership deed (if applicable), address proof, pharmacist documents (educational certificates, registration, photographs, appointment letter), qualified person documents (for wholesale), and property documents (rental agreement or ownership proof).

4. What is the fee for a retail drug sale license?

The fee for a retail license is Rs. 3000 (Rs. 1500 + Rs. 1500).

5. What forms are used for manufacturing licenses?

Form 24 for drugs other than Schedules C, C1, X; Form 27 for Schedule C and C1 drugs; Form 27B for Schedule C, C1, and X drugs; Form 30 for examination, test, or analysis.

6. How often must premises be inspected?

Premises licensed for the sale of drugs must be inspected at least twice a year. Premises licensed for the manufacture of drugs must also be inspected not less than twice a year.

7. What is e-Governance?

e-Governance is the use of Information and Communications Technology (ICT) in the governance process to overcome issues like red-tapism, lack of accountability and transparency, and to provide efficient delivery of public services.

SUMMARY

Good Regulatory Practices (GRP) are essential processes, systems, tools, and methods for improving the quality of regulations. They involve public consultation, stakeholder involvement, and impact analysis to ensure regulations are fit for purpose. The objectives include protecting public health and safety, promoting innovation, encouraging trade, improving market access, and ensuring reliability and quality.

The components of GRP include legislative authority, accountability, fairness, expertise, efficiency, evidence-based approach, risk assessment, transparency, regulatory impact assessment, systematic monitoring, and international standards. GRP is applied in community pharmacy, hospital pharmacy, manufacturing, wholesale business, import/export, and inspection, with e-governance increasingly being adopted to improve efficiency and transparency.

As I always tell my students: “Good Regulatory Practices are not just about compliance—they are about building trust. When regulations are developed with transparency, stakeholder engagement, and evidence, they serve the public interest and strengthen the healthcare system.”

REFERENCES AND FURTHER READING

• Drugs and Cosmetics Act, 1940 and Rules, 1945. Government of India.
• Pharmacy Act, 1948. Government of India.
• Central Drugs Standard Control Organization (CDSCO). (2022). Guidelines on Licensing. Retrieved from https://cdsco.gov.in.
• World Health Organization (WHO). (2022). Good Regulatory Practices Guidelines. Retrieved from https://www.who.int.
• Ministry of Health and Family Welfare. (2022). e-Governance Initiatives in Healthcare. Government of India.

Disclaimer: This article is for educational purposes only and does not constitute legal advice. Regulatory practices, fees, and documentation requirements may change over time—always refer to the latest official gazette notifications and consult qualified legal professionals for specific matters.

written by:
Dr. N. Sujith Kumar

Dr. N. Sujith Kumar is a pharmacy educator, Pharm.D graduate, and academic content creator from Jawaharlal Nehru Technological University Kakinada (JNTUK), where he completed his Doctor of Pharmacy (Pharm.D) degree between 2015 and 2021. He has more than 7 years of experience creating pharmacy educational content, writing study materials, and reviewing academic articles for pharmacy students. He has also contributed guest articles to pharmacy education platforms, including PharmD Guru. At D.PharmGuru, his work focuses on simplifying complex Diploma in Pharmacy (D.Pharmacy) subjects into easy-to-understand notes, practical explanations, and exam-oriented educational resources for students across India. His areas of focus include Human Anatomy and Physiology, Pharmaceutics, Pharmacology, Pharmaceutical Chemistry, Hospital and Clinical Pharmacy, and other core D.Pharmacy subjects.

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