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 Drug
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Drug includes –
(i) all medicines for internal or external use of human beings or animals and all substances intended to be used for or in the diagnosis, treatment, mitigation 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
(ii) 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 in human beings or animals, as may be specified from time to time by the Central Government by notification in the Official Gazette
(iii) all substances intended for use as components of a drug including empty gelatin capsules; and
(iv) such devices intended for internal or external use in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals, as may be specified from time to time by the Central Government by notification in the Official Gazette, after consultation with the Board
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Drugs regulated
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Allopathic Drugs
- Ayurvedic Drugs
- Homoepathic Drugs
- Unani , Siddha Medicines
- Blood, Blood components, Blood Products
- Medical Devices
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Object
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- To ensure safety, efficacy, purity and quality of Drugs.
- To prevent consumers from self-medication.
- To ensure availability of drugs at authorised prices.
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To create an awareness about the importance of proper storage of drugs.
- To eliminate irrational combinations /banned drugs.
- To study the problems and suggestions made by the stakeholder.
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To collect the information in general about the drug trade and take necessary steps.
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To prepare policy regarding drug matter.
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To prevent misuse of Narcotics drugs.
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Acts implemented
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Regulate
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To grant and renew licences for the following Categories of Drug Manufacturing Units .
- Allopathic Drugs
- Ayurvedic Drugs
- Homoepathic Drugs
- Unani ,Siddha Medicines
- Blood ,Blood Products
- Medical Devices
- To approve Plan of manufacturing premises for Drugs.
- To Grant Licences for Repacking of Drugs
- To Grant and Renew Licences for Drug Selling Units.
- To Grant Licences for Public Testing Laboratory.
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To issue various Certificates for Tenders, Exports as listed below:
- WHO GMP certificate
- No Conviction certificate
- Performance Certificate
- Free Sale Certificate
- Schedule M GMP Certificate
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To issue Quota of Narcotics Drugs under the Narcotics Drugs and Psychotropic Substances Act.
- To issue Transport Permits under NDPS Act.
- To investigate complaints received regarding drugs
- To carry out inspections of manufacturing and selling Units
- To draw samples of Drugs
- To conduct raids for those manufacturing spurious drugs /substandard drugs
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To take legal action against the offenders and prosecute
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To give approval to personnel as Competent Technical Person for Manufacturing, Testing.
- To educate the consumers for the safe use of Drugs .
- To take cognizance of the news items appearing in News papers, Magazines etc and take necessary steps/actions.
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On the samples which are reported to be not of standard quality, depending upon the findings of Government Analyst the action of suspension, cancellation of licences, prosecution is taken as per the guidelines of Drug Controller General of India.
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Non Compliance of Conditions of Licences
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FDA calls for explanation / issues Show Cause Notice for suspension or cancellation of licenses and wherever necessary files prosecutions.
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| Intelligence Branch |
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