Regulatory affairs - industrial pharmacy II - BP702TT

REGULATORY AFFAIRS INDUSTRIAL PHARMACY ll BP702TT B.PHARMA SEMESTER 7     Syllabus:   Introduction, Historical overview of Regulatory Affairs, Regulatory authorities,  Role of Regulatory affairs department,  Responsibility of Regulatory Affairs Professionals

 

1.  INTRODUCTION 

A regulatory affair (RA) is a profession which acts as the interface between pharmaceutical industry and drug regulatory authorities across the world. It is mainly involved in the registration of drug products in respective countries prior to their marketing. The current Pharmaceutical Industry is well organized, systematic and compliant to international regulatory standards for manufacturing of Chemical and Biological drugs for human and veterinary consumption as well as medical devices, traditional herbal products and cosmetics. The Regulatory Affairs department is an important part of the organisational structure of pharmaceutical companies. Internally it liaises at the interface of drug development, manufacturing, marketing and clinical research. Regulatory Affairs is actively involved in every stage of development of a new medicine and in the post-marketing activities with authorised medicinal products.

 

2.  Historical overview of Regulatory Affairs

 

1950s, multiple tragedies i.e. sulfanilamide elixir, vaccine tragedy and thalidomide tragedy have resulted in substantial increase of legislations for drug products quality, safety and efficacy.

 

The drug industry in India was at very primitive stage till 20th century. Most of the drugs were imported from foreign countries

 

Government passed the Poisons Act, 1919 to check and hold the control on cheap drugs available in market

 

The Poisons Act was followed by The Dangerous Drugs Act, 1930 which includes the regulation of cultivation, manufacturing, possession and trade of opium.

 

Following acts and rules were passed

 

• Drugs and Cosmetics Act, 1940: This act regulates the manufacturing, distribution, import and sale of allopathic, homeopathic, unani and siddha drugs.

• Drugs and Cosmetics Rules, 1945: This act regulates manufacture of Ayurvedic drugs for sale only, and not for consumption and use or possession.

• Pharmacy Act, 1948

• Drugs and Magic Remedies (Objectionable Advertisements) Rule, 1955: This rule regulates the advertisement of drugs in India.

• Drugs Prices Control Order, 1955 (DPCO) (under the essential commodities Act)

 

• Indian Patent Act 1970 (which came in force on 20 April 1972 and replaced Indian Patents and Designs Act of 1911): It serves as the basis for patent protection in India

 

• Drug prices capped: Drug Prices Control Order (DPCO) was introduced to control the high price against consumers

 

1980-1990:

The Indian industry has started investing in process development of API and created production infrastructure for the same

 

1990-2000:

A rapid expansion in domestic market has observed in pharmaceutical industry. The companies have started entering into Research and Development.

 

 

2000-2010:

This period is considered to be the Innovation and Research era. During these years, innovative research activity, patenting of the drugs formula, process, indication as well as merger of companies was started.

 

Patent Amendment Act 2005: Indian Government brought out the Patents (Amendment) Ordinance, 2004 to address the issues relating to the patent in the country which was later replaced by the Indian Patent (Amendment) Act, 2005. The new Act brought some crucial changes on the legal regime of patent protection so as to address patent issues in technology, chemicals and pharmaceuticals sectors.

 

Compulsory Licenses: Such licenses can be granted for manufacture and export of the drug products “to any country having insufficient or no manufacturing capacity, for the said product, to address public health problems”.

 

 

3. Regulatory authorities

 

The rules and regulations are being framed considering Global, Regional and National pharmaceutical trade as well as necessity of the drugs based on population of patient. Most of the national guidelines regarding the development and market authorization application of drug are based on Global and Regional Harmonized guidelines. Global Network regulatory is composed of the representatives of each country in the world

(a) Health Authority (HA): The Health Authority to prepare drug regulatory guidelines and guidance documents which are compliant and conformity to existing laws and regulations and also coordinate with Global and/or regional regulatory body and in consultation with Pharmaceutical Manufacturer’s Association issues technical requirements and process for Marketing Authorization Approval.

 

(b) Pharmaceutical Industry: Manufacturer develops drugs according to regulatory necessity of quality, safety and efficacy and applies for Marketing Authorization

4. ROLE OF REGULATORY AFFAIRS DEPARTMENT

 

·         The role of regulatory affairs professional is to act as liaison with regulatory agencies. Preparation of organised and Ensure adherence and compliance with all the applicable CGMP, ICH, GCP, GLP guidelines regulations and laws.

·         Providing expertise and regulatory intelligence in translating regulatory requirements into practical workable plans. A regulatory affair plays a crucial role in the industry and is involved in all stages of drug development and also after drug approval and marketing.

·         Pharmaceutical companies use all the data that has been observed during the discovery and development stages in order to register the drug and thus market the drug.

·        Throughout the development stages, pharmaceutical companies have to follow the strict rule and guidelines in order to ensure safety and efficacy of the drug in humans. 

·         DRA professional plays the crucial role in each phase of drug development and post marketing activities.

·         The pharmaceutical companies (DRA professionals of the company) accumulate all the date pertains to drug discovery and development stages and uses the same for the purpose of registration and marketing of drug.

·         RA professionals of the company have to abide the array of strict and guidelines throughout the drug development process, to ensure the drug and efficacy of drugs in the humans.

·         The Regulatory Affairs department also takes part in the drug development, marketing concepts and is a crucial requirement to approve the packaging and advertising of drug/product before it is used commercially. 

5. RESPONSIBILITY OF REGULATORY AFFAIRS PROFESSIONALS

 

·          The responsibility of RA is to ensure that their companies are complying with all of the system policy and laws pertaining to their business

·         Working with federal, state, and local regulatory agencies and staff on specific issues distressing their commerce i.e. working with Government agencies.

·          RA advice their companies on the various aspects of regulatory affairs and particularly the climate that would affect proposed actions. (i.e. describing the "regulatory climate" in the region of issues such as the endorsement of prescription drugs).

·         The Regulatory Affairs professional’s job is to keep an eye on the ever-changing legislation in all the countries, particularly, where company have an interest to register their products.

·          The RA professionals advice legally and technically at all stage both and help companies to save a lot of resources, time and money in drug development and its marketing.

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