For testing of Drugs & Cosmetics as stated under section 20 and 33 F of Drugs & Cosmetics Act 1940 & Rules thereunder, Maharashtra State has established Drugs Control Laboratory at Mumbai and at Aurangabad, under the Administrative control of the Commissioner, Food and Drug Administration (FDA), Maharashtra State.
To give a brief history, till the late sixties, testing of Drugs and Cosmetics was carried out in Haffkine Institute, Parel, Mumbai-12. In August 1968, an independent Laboratory under the name “Drugs Control Laboratory” was established in Dental College, St. George Hospital, Mumbai. In March 1970, this Laboratory was shifted to MHADA premises at Bandra (East), Mumbai-51. At present from September 1993, this Laboratory is functioning at its own premises at Plot No. 341, Bandra-Kurla Complex, Bandra (East); Mumbai-51.The Laboratory has the capacity to test about 6500 samples of Drugs & Cosmetics per year.
In order to test more number of samples of Drugs & Cosmetics, Maharashtra Government has established an additional Drugs Control Laboratory at Aurangabad. The Laboratory at Auragabad is testing about 2500 samples of Drugs and Cosmetics per year.
Organization & Structure:-
The Laboratory at Mumbai has 9 main divisions namely:-
2. Chemical I
3. Chemical II
9. Central Instrument
The Laboratory at Aurangabad has 7 main divisions as above, except Antibiotics and Vitamins.
Each Laboratory is headed by Assistant Director, under the Administrative Control of the Commissioner, Food and Drug Administration, Maharashtra State. The laboratory at Mumbai has 110 Number of staff including both Managerial and Technical, and at Aurangabad there are around 48 Number of staff, both Managerial and Technical.
The main Laboratory Divisions are headed by Government Analyst (Senior Scientific Officer or Notified Scientific Officer). The technical staff such as Senior Technical Assistant, Analytical Chemist, and Scientific Officer is engaged in analytical work.
All the technical staff from Assistant Director to lower technical staff is qualified, experienced and trained. The Laboratory has the policy to depute the technical staff regularly in reputed institute for training in order to upgrade their knowledge in the areas of drug testing and handling of sophisticated instruments.
All the testing divisions including the Central Instrument Division are equipped with modern sophisticated, computerized analytical instruments like IR, GC, HPLC, UV-Visible spectrophotometer etc including reference standards required for calibration.
All the activities, i.e. from the receipt of sample to final dispatch of the reports are computerized by using the software developed by HCL as per the requirements of FDA & Drugs Control Laboratory.
Brief function of each division:-
Coding of received samples and distribution to other analytical division for analysis.
2. Chemical I:-
Analysis of Bulk Drug & Drug Formulations like liquid oral products, ointments, creams, lotions, gels etc.
3. Chemical II:-
Analysis of Drug Formulations like tablets and capsules except Antibiotics and Vitamins.
Analysis of Antibiotic Formulations.
5. Vitamins: -
Analysis of Vitamins and nutritional supplement formulations.
Analysis of Ophthalmic, Large volume/Small Volume parenteral
preparations, Intramauscular / Intravenous injectables.
7. Pharmacognosy: -
Analysis of Ayurvedic Drugs and Surgical dressings.
Analysis of cosmetic products.
Food testing Laboratory has been started under the control of Commissioner, Food and Drug Administration, from February 2008, both at Mumbai and Aurangabad.
Present capacity of testing Food samples is 1200 at Mumbai and 720 at Aurangabad. Both the Laboratories are well equipped with sophisticated instruments.
These Laboratories are one of the High Tech Laboratory in State of Maharashtra.
At present, Drugs Control Laboratory, Mumbai is committed to achieve the excellence in testing of Drugs & Cosmetics as per IS/ISO/IEC/17025:2005, the International standard for the competence of testing and calibrating laboratories. The Laboratory has established its Quality Policy, Quality Objectives and prepared Quality Manual to comply with the requirements of IS/ISO/IEC/17025:2005 for getting Accreditation from National Accreditation Board for Testing and Calibration Laboratories. After compliance with the requirements with this International standards, the Laboratory has been assessed by the Assessment Team sent by NABL.The Assessment Team has recommended this Laboratory for NABL Accreditation both in Chemical and Biological Testing for the recommended scope as per ISO/IEC/17025:2005.
Recently Drugs Control Laboratory Mumbai has achieved prestigious NABL accreditation certificate for both Biological and Chemical field. Also, DCL is taking part in Inter Laboratory comparison testing programme.