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Drug
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Drugs regulated
- Allopathic Drugs
- Ayurvedic Drugs
- Homoepathic Drugs
- Unani , Siddha Medicines
- Blood, Blood components, Blood Products
- Medical Devices
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Object |
- To prevent consumers from self-medication.
- To ensure safety, efficacy, purity and quality of Drugs.
- To ensure availability of drugs at reasonable prices.
- 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.
- To collect the information in general about the drug trade.
- To educate consumers regarding safe use of Drugs.
- To prepare policy.
- To prevent misuse of Narcotics drugs.
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Acts implemented
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- The Drugs and Cosmetics Act 1940 and Rules 1945.
- The Drugs and Magic Remedies (Objectionable Advertisements) Act 1954 and Rules 1955.
- The Narcotics and Psychotropic Substances Act, 1985 and Rules, 1985.
- The Poisons Act, 1919 and Maharashtra Poison Rules, 1972.
- The Drugs Price (Control) Order, 1995.
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Regulate
- 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.
- 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
- Manufactuing and Marketing Certificate
- To issue Quota of Narcotics Drugs under the Narcotics 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
- To take legal action against the offenders and prosecute
- To give approval to personnel as Competent Technical Person for Manufacturing, Testing.
- To educate the consumers for the safe use of Drugs .
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| If the samples are reported to be not of standard quality then depending upon the findings of Government Analyst the action of suspension, cancellation of licences is taken. In case the sample is grossly failing legal proceedings are initiated against all concerned. |
| Non Compliance of Conditions of Licences |
| FDA calls for explanation / issues Show Cause Notice for suspension or cancellation of licenses and wherever necessary files prosecutions. |
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| For Information regarding Drug related matter, contact the Public Relation Officer at the concerned Office of FDA between 10.00 a.m. to 1.00 p.m. |
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