National Formulary of India
The Drugs and Cosmetics Act and Rules
Central Drugs Standard Control Organization (CDSCO)
Clinical trial rules
Pharma Jan Samadhan
Do’s and Don’ts for the consumers
What is drug?
Any substance or pharmaceutical product for human or veterinary use that is intended to modify or explore physiological systems or pathological states for the benefit of the recipient is termed as drug (WHO). The terms drug, medicine and pharmaceutical product are commonly used interchageably.
An Active Pharmaceutical Ingredient (API) is the chemical substance contained in a pharmaceutical, which is responsible for its therapeutic effect. Some pharmaceuticals contain more than one active ingredient (combination product).
Medicines are usually available under two names: a generic name and a brand name. India is emerging as a world leader in generic pharmaceuticals production, supplying 20% of the global market for generic medicines.
Generic medicines are unbranded medicines which are equally safe and having the same efficacy as that of branded medicines in terms of their therapeutic value. The prices of generic medicines are much cheaper than their branded equivalent.
The Generic Drugs have to pass all equivalency tests like patent drugs and are considered as therapeutic equivalent. This means that the drug will do the same thing via the same mechanism, and will also follow the same distribution, metabolism and elimination pathways in the body, just like brand name drugs.
Generic manufacturers are able to sell their products for lower prices because they are not required to repeat the costly clinical trials of new drugs and generally do not pay for costly advertising, marketing, and promotion. In addition, multiple generic companies are often approved to market a single product; this creates competition in the market place, often resulting in lower prices.
The terminology of generic medicine and brand name is different in India and USA (United States of America). In USA, there is only one brand for a particular drug molecule. This is the innovator’s brand and no one else is allowed to market this drug molecule within the patent protection period. On expiry of patent, marketing of the molecule under its generic name is allowed. There may be several generic versions of the branded one. Generic name is the common name of the drug molecule.
In India, there was only process patents and product patents concept came in 2005. Under process patent, Indian pharmaceutical companies can produce a drug molecule by a different process and market it as a brand of their choice hence there are several brands of the same drug molecule available in the market. They are not brands in true sense, as they are not marketed by the innovator. Hence they are called ‘branded generics’. These branded generics can be viewed as brands.
Thus in India there are several brands and several generic products of the same drug molecule unlike one brand and several generic versions in USA.
Impact of generics in public health The central and state governments are promoting generics in public hospitals through procurement under generic name and prescribing them. Use of generic medicines significantly reduces the cost of medicines to both governments and patients.
Essential medicines are those that satisfy the priority health care needs of the population.
These medicines are selected with due regard to disease prevalence, evidence on efficacy and safety, and comparative cost-effectiveness.
The essential medicines concept states that a limited number of carefully selected essential medicines, with proven efficacy, safety and quality, leads to better health care, better management of medicines and lower health care costs for the majority of the population with common diseases.
Essential medicines are intended to be available within the context of functioning health systems at all times in adequate amounts, in the appropriate dosage forms, with assured quality, and at a price the individual and the community can afford.
Ministry of Health & Family Welfare (MOHFW), Government of India is mandated to ensure the quality healthcare system by assuring availability of safe and efficacious medicines for its population.
The Central Drugs Standard Control Organization (CDSCO), MOHFW, Government of India works as the Central Drug Authority of India for discharging functions assigned to the Central Government under the Drugs and Cosmetics Act. The first National List of Essential Medicines (NLEM) of India was prepared and released in 1996.This list was subsequently revised in 2003,2011 and 2015.
Salient features of NLEM 2015: –
National lists of essential medicines (NLEM) India-2015 can be seen by clicking at
Drugs undergo rigorous testing before they are introduced into the market. They are first tested in animals and then in human beings during clinical trials. The efficacy as well as safety profiles of the drug are tested. In spite of this, some adverse effects of drugs appear only after the drug is used in the general population. These adverse effects are detected though a process of regular monitoring after the drug is released called pharmacovigilance.
If the adverse effects are severe or if the drug is ineffective, the country may ban the drug. Some drugs may have adverse effects only when combined with particular drugs. In such cases, only the fixed dose combination is banned and not the individual drugs. A number of individual drugs as well as fixed dose combinations are banned in India.
List of drugs prohibited for manufacture and sale through gazette notification under section 26 A of Drugs & Cosmetics Act 1940 by the Ministry of Health and Family Welfare released on 1st January 2018 can be seen at -https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTY4Mg==
National Formulary of India (NFI)
What is a formulary?
Formulary is a manual containing clinically oriented summaries of pharmacological information about selected drugs. The manual may also include administrative and regulatory information pertaining to the prescribing and dispensing of drugs. A national formulary generally concentrates on available and affordable medicines that are relevant to the treatment of diseases in a particular country. Formularies are also frequently created for different levels of health care, different sectors and for individual hospitals.
The first, second and third editions of National Formulary of India (NFI) were published in 1960, 1966 and 1979 respectively by the Ministry of Health, Government of India. In the past 3 decades there has been vast expansion in the range of new drugs and their formulations. To address the need of publication of an updated version of NFI, Ministry of Health and Family Welfare, Govt. of India assigned this mandatory responsibility to the Indian Pharmacopoeia Commission (IPC), Ghaziabad and hence the NFI is being published by the IPC on the behalf of Ministry of Health and Family Welfare, Govt. of India. This National Formulary has been adopted from the WHO Model Formulary and thoroughly updated for its content, especially keeping in view the end user in India.
To support the health care professional and other stakeholders on rational use of medicines and to full fill the mandate of the Indian Pharmacopoeia Commission, the 5th edition of NFI-2016 was published with 521 number of drugs monographs.
NFI 4th Edition 2011 can be seen at http://www.cdsco.nic.in/writereaddata/NFI_2011%20(1).pdf
5th Edition of NFI 2016- https://nabh.co/Announcement/National%20Formulary%20of%20India%20(NFI)%202016.pdf
The Drugs and Cosmetics Act and Rules
The Parliament of India formed an Act which regulates the import, manufacture and distribution of drugs in India. The primary objective of the Act is to ensure that the drugs and cosmetics sold in India are safe, effective and conform to prescribed quality standards. The Drugs Act was formulated in 1940 in pursuance of recommendations of Chopra Committee constituted in 1930 by Government of India. The drugs under the Drugs and Cosmetic Act cover wide varieties of therapeutic substances, diagnostics and medical devices.
Under the Act cosmetic means any article intended to be rubbed, poured, sprinkled, or sprayed on, or introduced in to, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting the attractiveness or altering the appearance, and includes any article intended for use as a component of cosmetic but does not include soap. The Act has been further amended as Drugs (amendment) Act 1964 (13 of 1964) to include Ayurvedic and Unani drugs.
The Drugs Act, as enacted in1940, has since been amended several times and is now titled as “The Drugs and Cosmetics Act, 1940”.
The drug rules were promulgated in December 1945 and enforcement of these rules started in 1947. The Rules have also been amended time to time to meet the needs of the time and to rectify any deficiencies noticed during the implementation.
The responsibility of enforcing the various Acts vests with the Central government and State/Union Territory (UT) governments. Under the Drugs and Cosmetics Act, the drugs are classified in schedules and regulations are laid down for their storage, display, sale, dispensing, leveling, prescribing etc.
Know details about Drugs and Cosmetics Act, 1940 and Rules,1945 As amended up to the 31st December 2016-cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-documents/acts_rules/2016DrugsandCosmeticsAct1940Rules1945.pdf
Central Drugs Standard Control Organization (CDSCO)
The Central Drugs Standard Control Organization (CDSCO) is the central drug authority established for discharging functions assigned to the central government under the Drugs and Cosmetics Act. It works under Directorate General of Health Services, Ministry of Health & Family Welfare, Government of India. CDSCO has six zonal offices, four sub zonal offices, thirteen port offices and seven laboratories across the country.
Under the Drugs and Cosmetics Act, CDSCO is responsible for approval of new drugs, conduct of clinical trials, laying down the standards for drugs, control over the quality of imported drugs in the country and coordination of the activities of State Drug Control Organizations by providing expert advice with a view to bring uniformity in the enforcement of the Drugs and Cosmetics Act.
To know more about CDSCO –Click Here
Pharmacovigilance is defined as the science and activities concerned with the detection, assessment, understanding and prevention of adverse reactions to medicines (i.e. adverse drug reactions or ADRs). The ultimate goal of this activity is to improve the safe and rational use of medicines, thereby improving patient care and public health.
Adverse Drug Reactions (ADR) or adverse reaction is defined as a response to a medicine used in humans or animals, which is noxious and unintended, including lack of efficacy, and which occurs at any dosage and can also result from overdose, misuse or abuse of a medicine.
For the purposes of registration, a clinical trial is any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes. Clinical trials may also be referred to as interventional trials. Interventions include but are not restricted to drugs, cells and other biological products, surgical procedures, radiologic procedures, devices, behavioural treatments, process-of-care changes, preventive care, etc. This definition includes phase 1 to phase IV trials.
New Drugs and Clinical Trials Rules 2019 G.S.R. 227(E)- MARCH 19, 2019/ can be seen at
Pharma Jan Samadhan
The Pharma Jan Samadhan (PJS) initiative is part of Goverment of India's Digital India initiative, which aims at empowering the citizen through a transparent, accountable and responsive governance system.
The PJS provides the consumer with an effective and time bound grievance redressal system to effectively deal with complaints related to pricing, shortage and non-availability of medicines. Apart from the internet- based online facility, there is a consumer Help Line also, which can be used to lodge complaints. Complaints may also be sent to:
NPPA, 3rd Floor, YMCA Cultural Centre Building,
1, Jai Singh Road, New Delhi – 110 001.
Tel: 011 – 23746649
Fax: 011 – 23746652
Help Line no. : 011 – 23746647
Search for medicine prize fixed by National Pharmaceutical Pricing Authority-Click here
Dos and Don’ts for the consumers