All medicines for internal or external use of human or animals and all substances intended to be used for or in the diagnosis, treatment, mitigation (decreasing) or prevention of any disease or disorder in human beings or animals, including preparations applied on human body for the purpose of repelling insects like mosquitoes; and Such substances (other than food) intended to affect the structure or any function of the human body or intended to be used for the destruction of vermin or insects which cause disease to human beings or animals. All substances intended for use as components of a drug including empty gelatine capsules; and Such devices intended for internal or external use in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals.

Foreign pharmaceutical companies nowadays have a better legal foundation (patents) for releasing new drugs in India. General policies toward foreign investment have also improved significantly. The timing of these structural changes coincide with India’s growing demand for newer classes of drugs as well as their increasing ability to afford international prices. Although recently developed foreign drugs are now increasingly able to take advantage of India’s drug demand growth, the Indian medical regulatory system has become more complicated, and new drugs can take a year or more to be approved for marketing.

Pacific Bridge Medical’s pharma consultants have years of experience with developing and implementing effective regulatory strategies that comply with India’s regulations. You can count on our expert consultants for assistance with the efficient and timely registration of your pharmaceutical or API product in India.

What is Regulation?

To regulate means to control something so that it functions properly Drug Regulatory Affair is a comparatively new profession which is developed by government to protect public health, by controlling the safety and efficacy of products in areas including pharmaceuticals, veterinary medicines, medical devices, pesticides, agrochemicals, cosmetics and complementary medicines.

Drug Regulatory System In India

Legal Enactments to Regulate Import, Manufacture & Sale of Drugs Drugs and Cosmetics Act, 1940 Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954 Drugs and Cosmetics Rules, 1945 made under the Act Drug Price Control Order (DPCO), 1995

Drug Regulatory Structure In India

Connections with the Central Legislative Assembly Ministry of Chemicals & Fertilizers Ministry of Health Ministry of Sci & Tech Ministry of Enviro NPPA National Pharmaceutial Pricing Authority Pricing Regulations Health Secretary DGHS DCGI Drug Controller General of India Govt. Drug Testing Laboratories Approval of New Drug DBT Dept. of Biotechnology Additional Secretary GEAC Genetic Engineering Approval Committee

Regulatory Process for Approval of a New Drug in India

An Application to conduct clinical trials in India should be submitted along with the data of chemistry, manufacturing control and animal studies to DCGI .The date regarding the trial protocol, investigator’s brochures, and informed consent documents should also be attached. One copy of the application must be submitted to the Ethical Committee. The clinical trials are conducted only after approval of DCGI and Ethical Committee.

Procedure to obtain Drug Selling Licence(Fresh)

Application for grant of Selling Licence

The applicant has to make application in the requisite Form viz 19, 19A,19B, 19AA details of Forms and pay

Documents to be attached along with the application form:

1. Requisite Application Form.

2. Receipt for the fees paid or challan, as the case may be or their attested copies.

3. Layout plan of selling premises in 3 copies.

4. Documents viz. rent receipt, purchase documents or its attested copies showing lawful possession of the premises.

5. Documents relating to the constitution of the firm viz. Partnership-deed, memorandum and article of association etc.

6. Full particulars of the competent technical staff /registered persons along with copies of their educational qualification, experience and registration certificates.

7. Full name of the proprietor or the partners, as the case may be shall be provided in the application. In case of private or public limited concerns, full name of the Directors who sign the application and the authorised signatory, if any , shall be provided in the application.

8. Documents for the purchase of Refrigerator/Deep freezer (For Vaccines / Sera).

Inspection

The application is scrutinized and premises inspected.

Grant of Licence

If all conditions as prescribed by the act are complied licence is granted.

Download

Application Forms ( 19 ,19A , 19AA ,19B, 19C )

Procedure to Renew Drug Selling Licence

Licenses in Forms 20, 21, 20B, 21B, 20A, 21A, 20C, 20D, 20F, 20G, 20BB, 21BB be renewed.

Application for renewal of Drug Selling Licence

The applicant has to make application in the requisite Form 19, 19A, 19B, 19AA and pay Necessary fees as given in fee chart in

Documents to be enclosed along with application of renewal of licence :-

1. Copy of cash receipt or challan for payment of fees.

2. Xerox copy of Licence /Previous renewal certificate.

3. Documents viz. rent receipt, purchase documents or its attested copies showing lawful possession of the premises.

Full particulars of the competent technical staff /registered persons along with copies of their educational qualification, experience and registration certificates.

Inspection

The application is scrutinized and premises inspected .

Grant of Licence

If all conditions as prescribed by the act are complied licence is granted

Download

Application Forms (19 ,19A , 19AA ,19B , 19C )