The Central Drugs Standard Control Organization (CDSCO) under Directorate General of Health Services, Ministry of Health & Family Welfare, and Government of India is the National Regulatory Authority (NRA) of India.

Under the Drugs and Cosmetics Act, CDSCO has many responsibilities which includes approval of Drugs to direct Clinical Trials, Provide standards for Drugs, quality check of imported Drugs in the country and coordinate with the State Drug Control Organizations for the activities by providing expert advice, training keeping in mind the uniformity in the implementation of the Drugs and Cosmetics Act.

Moreover CDSCO along with State Drug Control Organizations is together responsible for permit of licenses of certain specialized type of critical Drugs.

Role of Central Drugs Standard Control Organization

Under the Drug & Cosmetics Act, the arrangement of manufacture, sale & distribution of Drug is firstly the priority of State Authorities while Central Authorities are only responsible for the giving permission to new drugs, clinical experiment in the country, providing standards for drugs, to check quality of the imported drugs, coordinating with the State Authorities.

CDSCO is also a part of giving permission to specified categories of drugs such as blood and blood products, I. V. Fluids, Vaccine.

• Giving permit to new drugs and clinical trials
• Import Registration & licensing
• License approval of Blood banks, LVP’S, Vaccine, r-DNA Product & some medical devices
• Amendment to D & C Rules
• Banning of Drugs & Cosmetics
• Grant of test license, Personal License, NOC’s for export
• Testing of New Drugs

Central Drugs Standard Control Organization has 8 Division in which it deals. Following are the list of CDSCO divisions:

• New Drugs
• BA/BE
• Import & Registration
• Biological
• Cosmetics
• Clinical Trials
• Medical Device & Diagnostics
• DCC-DTAB

New Drugs

Demonstration of safety and efficacy of the drug product for use in humans is essential before the drug product can be approved for import or manufacturing and marketing in the country.

The Rules 122A, 122B, 122 DAB, 122DAC, 122 DD and 122E of Drugs and Cosmetics Rules give the information, data required for approval of clinical trial and or to import or manufacture of newly introduced drug for marketing in the country.

New drugs as defined under Rule 122-E of Drugs and Cosmetics Rules, New drugs including bulk drug substance or Phytopharmaceutical drug which has not been used in the country to any remarkable extent under the conditions, recommended or suggested in the labelling there of and has not been acknowledge as effective and safe by the licensing authority mentioned under rule 21 for the proposed affirmation.

A drug that have already approved by the Concerned Authority mentioned in Rule 21 for certain affirmation, which is now proposed to be marketed with modification or new affirmation, indications, namely (storage, dosage form (quantity) and route of administration.

Fixed dose mixture of two or more drugs, individually approved earlier for certain affirmation, which are now proposed to be combined for the first time in a fixed quantity, or if the ratio of ingredients is an already marketed combination is proposed to be changed, with certain affirmations, viz. indications, dosage, dosage form (including sustained release dosage form) and route of cause.

Drugs derived from the vaccines and Recombinant DNA (r-DNA) shall be considered as new drugs unless it is certified by the Licensing Authority under Rule 21. From the date of first-time approval of a new drug it shall be considered as a new drug for a period of 4 years.

Medical Device & Diagnostics 

In India, at present only notified medical devices are regulated as Drugs under the Drugs and Cosmetics Act and Rules made there under in 1945.

• Substances used for artificial insemination detection and incision dressings, incision bandages, incision staples, incision sutures, ligatures, blood and blood component collection bag with or without anticoagulant.
• Substances including prophylactic techniques (birth control contraceptive (condoms, I-pill, unwanted – 72), intrauterine devices, tubal rings), antiseptic and insect killer.

List of Medical Devices

• Disposable Hypodermic Syringes
• Disposable Hypodermic Needles
• Disposable Perfusion Sets
• In vitro Diagnostic Devices for HIV
• HBsAg and HCV
• Cardiac Stents
• Drug Eluting Stents
• Catheters
• Intra Ocular Lenses
• I.V. Cannulae
• Bone
• Heart Valves
• Scalp Vein Set
• Orthopedic Implants
• Internal Prosthetic Replacements
• Ablation Devices

Drugs Import & Registration                               

• The import of Drugs into India is regulated under Chapter III of Drugs & Cosmetics Act & Part IV of Drugs & Cosmetics Rules.
• The applications for registration certificate & import license of drugs are processed as per the Drugs & Cosmetics Rules.

Drug includes:

• All the substance that has medicinal properties and can be used internally or externally in human beings or animals and all substances which can be used for or in the detection, cure, reduction of any disease or disorder in human beings or animals, also includes mixtures applied or sprayed on human body for the purpose of repelling or distancing the insects from the human body like mosquitoes.
• Such substances (other than food) are just used to alter the structure or any function of the human body or intended to be used for the destruction of insects which cause disease in human beings or animals.

Rules Governing Clinical Trials

• Rule 122-A -Registration for permission to import new drug
• Rule 122-B -Registration for approval to manufacture new drug
• Rule 122-DA -Necessary requirement of permission from DCG for conduct of clinical trial of new drug;
• Rule 122 DAB -Provision for compensation during a clinical trial related case. Provision for cancelling of the license of the applicant in case of failure to pay compensation
• Rule 122 DAC -Requirement of permission for conduct of clinical trial which includes necessary requirement to follow Good Clinical Practice (GCP) guidelines, guidelines and requirements given in Schedule Y of Drugs and Cosmetics Rules. Provision for cancellation of license of applicant and investigator in case of failing to do compliance
• Rule 122 E -Definition of new drug
• Schedule Y -Detailed instruction and essential details for the procedure to conduct clinical trial and approval of new drug
• Good Clinical Practice Guidelines -Issued by Central Drug Standard Control Organization and Directorate General of Health Services, Govt. of India

BA/BE

• Bioavailability (BA): Bioavailability may be defined as the respective amount of drug that reaches the systemic circulation and so able to have an active effect in the body.
• Bioequivalence (BE): Two drugs are said to be Bioequivalence drugs if they function same in all intent by giving in equivalent proportions. 

Biological

• Biological products or biologics are medical products. Most of the biological present on earth is made from a variety of natural sources (human, animal or microorganism). Like some medicine, some biologics are intended to treat diseases and medical conditions. Other biological products are used to prevent or diagnose diseases. 

Vaccines

• Blood and blood derive products for transfusion and/or manufacturing into other products
• Allergenic extracts from plants, which are used for both diagnosis and treatment (for example, allergy shots)
• Human organs or cell or tissue used for transplantation (for example, tendons, ligaments and bone)
• Gene therapies
• Cellular therapies
• Blood donor test to screen for infectious agents such as HIV 

Cosmetics

According to Drugs and Cosmetics Act, “Cosmetic” means “any article that is intentionally used, pat, sprinkled or sprayed on, or introduced into, or otherwise applied to, the human body or any part thereof for cleaning, decorate, enhancing glow, or changing the appearance and includes any article intended for use as a component of cosmetic.”

Under the provisions of Drugs and Cosmetics Act, and Rules made there under, the manufacture of cosmetics is regulated under a system of inspection and licensing by the State Licensing Authorities appointed by the concerned State Governments while the import of cosmetics is regulated under a system of registration by the Licensing Authority appointed by the Central Government. The Drugs Controller General (India) functions as the Licensing Authority who grants the registration certificate and regulates the import of cosmetics in India under the provisions of Drugs and Cosmetics Act, and Rules made there under.

DCC-DTAB

DTAB & DCC gives the recommendations on the matters rose out of administration of the Drugs and Cosmetics Act and Rules there under shall be done by amending the relevant particulars of the Drugs and Cosmetics Act and Rules there under.

DCC – DTAB also organizes the meeting for effective monitoring of the rules.