The pharmaceutical industry discovers, develops, produces, and markets drugs or pharmaceutical drugs for use as medications to be administered (or self-administered) to patients, with the aim to cure them, vaccinate them, or alleviate the symptoms.

1. A presentation on
Pharmaceutical industry development
By
Santosh Kumar-MPH/10019/22
Department of pharmaceutical science and Technology
Birla institute of technology, Mesra
Ranchi- 835215(Jharkhand)
2022

2. CONTENTS
❑ Overview
❑ Legal requirements and licenses for API and
formulation industry
❑ Manufacturing or importing of drugs
❑ Application and data required
❑ Drug approval process in India.
❑ Reference

3. ❑ Overview
Pharmaceutical Industry Developments
• The pharmaceutical industry discovers, develops, produces, and
markets drugs or pharmaceutical drugs for use as medications to be
administered (or self-administered) to patients, with the aim to cure
them, vaccinate them, or alleviate the symptoms.
• Pharmaceutical companies may deal in generic or brand
medications and medical devices.
• They are subject to a variety of laws and regulations that govern the
patenting, testing, safety, efficacy and marketing of drugs.

4. Legal requirements and Licenses for API and Formulation industry
All new drugs (drugs not previously used in India or in use for less than four years)
proposed to be introducedmust be approved for import or manufacture in India by the
DCGI.
The full set of data to be submittedconsistsof:
• Introduction:description of drug and therapeutic class
• Clinical and pharmaceutical information
• Animal pharmacology
• Animal toxicology
• Human/ clinical pharmacology (Phase I)
• Exploratoryclinical trials (Phase II)
• Confirmatory clinical trials (Phase III)
• Special studies Regulatory status in othercountries.
• Marketing information

5. Manufacturing or importing of Drugs
• To manufacture or import Active Pharmaceutical Ingredient (API)/drugs to
India, the company or the organization should seek prior approval from
Drugs Controller General Of India (DCGI) for licensing to produce and
distribute..
• To produce the drugs, the company should also follow the norms as
stipulated by the Central Drugs Standard Control Organization (CDSCO).
• The DCGI and CDSCO will be monitored by the Ministry of Health and
Family Welfare.
• To support DCGI and CDSCO for widening scope and research,
Government of India (GoI) has formed the Drug Technical Advisory Board
(DTAB) and Drug Consultative Committee (DCC).

6. Any new drug that is yet to be introduced into the country
should conduct trails, collect sample data, approvalprocess
and adhere to Appendix 1, IA and VI of Schedule Y and the
following rules as mandated by the Drugs and Cosmetics Act
1940 and Rules 1945:
1. Rule 122 A- Permission to Import new Drugs
2. Rule 122 B- Permission to Manufacture new Drugs
3. Rule 122 DA- Definition of Required clinical trials
4. Rule 122 E-Definition of Drugs

7. The following are the rules and regulations Guidelines
that should be followed By the company to introduce the
new drug in India:-
1. Drugs and Cosmetics Act 1940 and its rules 1945
2. Narcotic Drugs and Psychotropic Substances of 1985
3. Drugs Price Control Order of 1995.
4. Protection Act of 1986
5. ICH GCP Guidelines
6. Schedule Y Guidelines
7. ICMR Guidelines

8. Application and Data Required
To seek permission to manufacture or import new drugs
for production, marketing or for clinal trials, the
company should attach the following data in Form 44 as
stipulated by Schedule Y (Rules 122A, 122B, 122D, 122DAA AND
122E):
• Chemical and Pharmaceutical details, as mentioned in item 2 of
Appendix I
• Data of Animal Pharmacology, as mentioned in item 3 of
Appendix I and Appendix IV
• Actions taken for general pharmacology as prescribed
in item 3.3 of Appendix I and item 1.2 of Appendix IV

9. • Pharmacokinetic data with respect to the
absorption, distribution, metabolism and excretion of the test
substance as prescribed in item 3.5 of Appendix I
• Data of Animal Toxicology, as mentioned in item 4 of Appendix I and
Appendix III
• Regulatory Status, as mentioned in item 9.2 of Appendix I
Details related to marketing new drugs as mentioned in item 10 of
Appendix I
• Protocols and methods involved for testing quality, as mentioned
in item 11 of Appendix I
• If the drug involved in the study has to be imported, details should be
furnished in Form

10. Drug approval process in
India.

11. Reference
1. https://www.indiafilings.com/learn/manufacturing-or-
importing-api-drugs/
2. https://www.researchgate.net/publication/303279229 OVER
VIEW OF DRUG REGISTRATION REQUIREMENTS F OR PHARMACEUTICALS IN
EMERGING MARKET
3. https://cdsco.gov.in/resources/guidance_on_approval of clinical trials and new
drugs
4. http://www.ncbi.nlm.nin.gov/pmc/articles/PMC3148610/
5. https://sciencedirect.com/topics/pharmaceuticals regulations