Legislation	Regulation
Passed by the legislative body of a country	Regulations are issued by the government, by an individual minister
General framework of principles within which the government is expected to act	It’s a part of legislation
The process of preparing or reviewing legislation is usually long and complex	The preparation and updating of regulations is a more dynamic process

What is the purpose of Pharmaceutical legislation?

To ensure that we receive drugs of required quality, tested and evaluated for safety and efficacy for their intended result

History of Pharmaceutical units

Year	Name of Founder	Name of shop/ Industry
1811	Mr. Bathgate (East India Company)	Chemist Shop in Calcutta
1821	Mr. Smith Stainstreet and Co.	Apothecary Shop
1901	Acharya Praffula Chandra Ray (Calcutta)	The Bengal Chemicals and Pharmaceutical Works
1903	Prof. T.K Gajjar	Factory at Parel
1907	Prof. Kotibhaskar	Alembic Chemical works, Baroda
1943	Amba lal Sarabhai	Sarabhai chemical Works

R. N. Chopra Committee

Reasons for formation of R. N. Chopra Committee:

Units were not sufficient to fulfill the requirements of Indian Public
Drugs were imported form UK, Germany and France
During first world war cheaper drugs were imported into India, which increased the demand for indigenous drugs
Unhealthy competition grew up and Indian market was flooded with inferior quality drugs

Public pressurized government to introduce effective legislation to control import, manufacture, distribution and sale of drugs
There was no legal and effective control on pharmacy profession
Hence to have a comprehensive legislation, the Indian government appointed a ‘Drug Enquiry Committee’ under the chairmanship of Col. R.N. Chopra in 1931. this was formally known as Chopra Committee

Recommendations of Drug Enquiry Committee

Formation of Central Pharmacy Council (PCI) and State Pharmacy Council
Creation of Drug Control Machinery (DCM)
Establishment of well-equipped Central Drug Laboratory (CDL) and State Drug Laboratory
A central law to control drugs and pharmacy profession
Appointment of an advisory board to advise Government in making rules
Setting up the courses for training of pharmacists and prescribing minimum qualifications for registration as pharmacists
Registration of every patents and proprietary medicines manufactured in India and imported from abroad
Bringing of crude single drugs as well as compounded medicines used in the indigenous systems of treatment under control
Development of the drug industry in India
Compilation of an Indian Pharmacopoeia

Implementations:-

q Due to Second World War in 1939, there was delay in introduction of the legislation

q Government was reluctant to implement the recommendations of DEC and the public was pressurizing the government

q Finally an Import of Drug Bill was introduced in 1937

q This bill dealt with only import of drugs and manufacturing and sale of drugs was not included

Scope and objective

• Drug bill was introduced in 1940 in legislative assembly, and Drug Bill 1940 was passed, which came to force in 1947

• Since then act was amended many times and at present it covers the provisions related to Drugs, Cosmetics, Ayurvedic, Unani and Homeopathic medicines

• The present Drug and Cosmetic Act is an improved version of the Drug Act, 1940. The main objective of this act was to regulate the import, manufacture, distribution and sale of drugs and cosmetics in India

• The Central Government made several rules entitled the Drug and Cosmetic Rules 1945. These act and rules were amended from time to time

• The Pharmacy act 1948 was passed with the main objective to regulate the profession of Pharmacy in India

• In 1954 the Drug and Magic Remedies Act was passed with the main aim to control certain types of advertisements related to drug and to prohibit certain types of advertisements related to magic remedies

• Medicinal and Toilet Preparations (Excise duty) Act, 1955 was passed providing for the levy and collection of duties of excise on medicinal and toilet preparations containing alcohol, opium Indian hemp or other narcotic drugs

• Central government implemented Drug Price Control order 1987

• In 1985 the Narcotic and Psychotropic Substance Act, was passed. The main objective of this act was to consolidate and amend the laws relating to narcotic drugs and Psychotropic substance

Bhore committee

• In 1943 under the chairmanship of Sir Joseph Bhore

• To make a survey of existing position in respect to health care delivery in India

• 7 key recommendations:

• Establishment of All India Pharmaceutical Council and Provincial Pharmaceutical Council

• Enactment of legislation designed to protect the public from incompetence, safeguard the
interests of qualified pharmacists and to raise the professional standard of pharmacists

• Suitable measures for maintaining disciplinary control over the practice and profession of pharmacy and for registration of pharmacists

• Starting of revised courses of study for Licentiate Pharmacists, Graduate Pharmacists, Pharmaceutical Technologies

• Setting up of Central Drugs Laboratory

• Rigid enforcement of Drugs and Cosmetics Act 1940 throughout the country

Bhatia committee

• In 1953 under the chairmanship of Major General S.L.Bhatia formed Pharmaceutical Enquiry committee to enquire into the working of pharmaceutical industry and to recommend what steps the Govt. should take to establish it on sound lines to improve the country’s economy

• In June 1954, 212 recommendations were submitted and most of the recommendations were implemented

Mudaliar committee

• In 1959 under the chairmanship of Dr. A.Lakshmanaswamy Mudaliar

• Inclusion of indigenous systems of medicine under the purview of Drugs Act

Hathi committee

• Under the chairmanship of Jaisukh Lal Hathi to review the various facets of drug industry in India

• Report covers licensing, price control, imports, QC, role of foreign sector etc

• Encourages development of indigenous industries

• Controlled the prices of large number of drugs in public interest

Indian Pharmacopoeia

v Bengal Pharmacopoeia and General Conspectus of Medicinal Plants – 1844

v 1st Pharmacopoeia of India – 1868

v British Pharmacopoeia -1885

v Indian Pharmacopoeia Committee – 1948

v The Indian Pharmacopoeia (1^stEdition) – 1955

v The Indian Pharmacopoeia (2^nd Edition) – 1966

v The Indian Pharmacopoeia (2^nd Edition) – 1975 – Supplement

v The Indian Pharmacopoeia (3^rd Edition) – 1985

v The Indian Pharmacopoeia (4^th Edition) – 1996

v The Indian Pharmacopoeia (5^th Edition) – 2007

v The Indian Pharmacopoeia (6^th Edition) – 2010

v The Indian Pharmacopoeia (7^th Edition) – 2014

v The Indian Pharmacopoeia (8^th Edition) – 2018

Other acts included were

v Prevention of food Adulteration act, 1954 and rules.

v The Industries (Development and Regulations) Act, 1951.

v The Industrial Employment (Standing order) Act 1946 and rules.

v Industrial Dispute Act, 1947.

v Factory Act, 1948.

v The Indian Patent and Design Act 1970.

v The Trade and Merchandise Mark, 1958.

v Shops and Establishment acts of respective states.

Indian Pharmaceutical Industry

Industry background

The Indian pharmaceuticals market increased at a CAGR of 17.46 per cent during 2005-16 with the market increasing from US$ 6 billion in 2005 to US$ 36.7 billion in 2016 and is expected to expand at a CAGR of 15.92 per cent to US$ 55 billion by 2020.

By 2020, India is likely to be among the top three pharmaceutical markets by incremental growth and sixth largest market globally in absolute size.

India’s cost of production is significantly lower than that of the US and almost half of that of Europe. It gives a competitive edge to India over others.

Issues for the Industry

} Between 2012-2018, the “patent cliff” will wipe an estimated $148 billion off pharmaceuticals industry revenues due to many drugs coming out of patents

} Rising cost of R&D, the cost of bringing a molecule to market globally is estimated to be from $800 million to $4 billion.

} On average, out of every 10,000 molecules been developed; only one or two are likely to reach the market.

} Increasing government pressure, with harsher price controls and taxes.

} European Medical Agency (EMA) and the US Food and Drug Administration (USFDA) are focusing on risk management; thereby putting pressures on profitability of pharmaceutical companies.

} Reaching the rural market, which is very large in India, the pharmaceutical companies have to work with innovative marketing and sales tools to reach these markets.

} The contribution from the government in the areas of health care is not satisfactory, which is only 1.2 percent of the GDP and healthcare infrastructure development not up to the expectation in India.

key legislations that regulate the pharmaceutical industry in India

Drugs and Cosmetics Act, 1940:
- This is the primary legislation that regulates the import, manufacture, distribution, and sale of drugs and cosmetics in India.
- It sets the standards for the quality, safety, and efficacy of drugs and cosmetics.
- The Central Drugs Standard Control Organization (CDSCO) is the regulatory authority responsible for implementing and enforcing the provisions of this act.
Drugs and Cosmetics Rules, 1945:
- These rules provide detailed provisions and guidelines for the implementation of the Drugs and Cosmetics Act.
- They cover aspects such as licensing of manufacturing and sales, clinical trials, import and export of drugs, and other regulatory processes.
Schedule Y:
- This schedule, under the Drugs and Cosmetics Rules, provides the requirements and guidelines for the conduct of clinical trials for pharmaceutical products.
- It outlines the ethical considerations, regulatory approvals, and documentation required for conducting clinical trials in India.
New Drugs and Clinical Trials Rules, 2019:
- These rules replaced the earlier Schedule Y and brought in significant changes in the regulatory framework for clinical trials in India.
- They aim to streamline and expedite the approval process for new drugs and clinical trials while ensuring the safety of participants.
Pharmacy Act, 1948:
- This act regulates the education and practice of pharmacy in India.
- It establishes the Pharmacy Council of India (PCI) to regulate and develop the pharmacy profession.
National Pharmaceutical Pricing Authority (NPPA):
- The NPPA is responsible for fixing and regulating the prices of pharmaceutical products in India to ensure their affordability and availability.
Intellectual Property Rights (IPR):
- India complies with international agreements related to intellectual property, including Trade-Related Aspects of Intellectual Property Rights (TRIPS).
- The Patents Act, 1970, governs the grant and protection of patents in the pharmaceutical sector.
Good Manufacturing Practices (GMP):
- GMP guidelines ensure that pharmaceutical products are consistently produced and controlled according to quality standards.
- The WHO-GMP guidelines are often adopted by pharmaceutical companies in India.