- Established Quality Systems in accordance with international Standards including EDQM, TGA and USFDA.
- Preparation & filing of Drug Master Files for API & Dossiers (formulations) for registration in various countries.
- Authored / Reviewed more than 100 Drug Master Files & Dossiers for API and submitted to – EDQM, USFDA, MCA-UK, Irish Board of Medicine, Canadian Drug Authorities, TGA – Australia, Federal Institute for Drugs and Medicinal Products, Germany etc.
- Led the Companies successfully through inspections and / or approvals:
EDQM, USFDA, MCA – UK, Irish Board of Medicine, TGA – Australia, Certificates of Suitability, National Board of Health & Medicine, SWEDEN (on behalf of UNICEF WHO), MCC – South Africa.
- The Company (KAPL) won five times IDMA Quality Excellence Award.
- ISO 9001: 1994 &ISO 9001: 2000 accreditation.
FORMULATIONS: Setting up of Manufacturing Facilities for Sterile & Non-sterile Dosage Forms as per cGMP requirements.
API & INTERMEDIATES: Setting up and up-gradation of Manufacturing Facilities as per cGMP requirements.
Management: Advanced Management Program (one month residential Course) for Senior Public Sector Executives at Administrative Staff College of India, HYDERABAD.
Biotechnology: Advanced H I V testing at Genetic Systems Corp., Seattle, U S A, Advanced Immunological Techniques at All India Institute of Medical Sciences, New Delhi
ISO: ISO 9001 Auditor / Lead Auditor Training Course by TQMI. ISO 9001:2000 Transition Auditor Training Course by BVQI
ANDA: Orientation at TOR Pharma, Canada
PUBLICATIONS & OTHER ACHIEVEMENTS
Speaker at 52nd IPC congress at Hyderabad
Faculty at Workshop on GMP & Quality Assurance at PERD center, Ahmedabad
Ph.D.( Microbiology) in 1979, from All India Institute of Medical Sciences, New Delhi
M.Sc (Hon’s.), Microbiology from Punjab University, Chandigarh
B.Sc. (Hon’s) – with distinction, in Microbiology
September 2002 – Present
Director, CPC India Limited
February 2001 – September 2002
President (Corp. Quality), Dishman Pharmaceuticals & Chemicals Ltd. Ahmedabad
In Technical Collaboration with M/S Solvay Pharmaceuticals, Netherlands for the manufacturing of Eprosartan mesylate
July 1997 – March 2001
Vice President (Corporate Head Regulatory and Quality – API & Formulations), Nicholas Pharma India Ltd (4th largest pharmaceutical company in INDIA
June 1995 – July 1997
Senior General Manager & Head Total Quality Management (API & Formulations), SOL Pharmaceuticals Ltd, Hyderabad.
USFDA inspected facility for Sulphamethoxazole
April 1991 – June 1995
General Manager / Dy General Manager (Immunodiagnostics), Karnataka Antibiotics & Pharmaceuticals Ltd., Bangalore
Tie-up with M/S Sanofi Diagnostic Pasteur, Paris France for the marketing and subsequently manufacturing of AIDS Kits in India
June 1983 – April 1991
Dy General Manager/Head Total Quality Management (Formulations), Karnataka Antibiotics & Pharmaceuticals Ltd., Bangalore
A subsidiary of HAL Pimpri, Pune – Manufacturing Injections, Tablets, Capsules, dry syrups, liquid orals, Veterinary products
Approval by National Board of Health & Welfare, Sweden
(On behalf of UNICEF WHO)
IDMA quality excellence award – 5 times
Nov. 1977 – June 1983
Head Microbiology, Pharmacology (Quality Control), IDPL – Gurgaon