FEEBLE REGULATORY AFFAIRS WEAKEN THE BACKBONE OF INDIAN DRUG INDUSTRIES

Journal Title: International Journal of Drug Regulatory Affairs - Year 2014, Vol 2, Issue 4

Abstract

India is emerging as a global outsourcing power house in almost all fields including Drugs and Pharmaceutical sector. Now it becomes a hub to conduct clinical trials and contract researches. Pharmaceutical industry currently opts for total quality management as primary criteria to prevent sub-standard products which do not fall under official specifications. However, there are many areas where immediate regulatory measures are desired. Central Drugs Standard Control organization (CDSCO) is the prime regulatory authority for the purpose of enforcement according to the Drugs and Cosmetic Act 1940 and Rules 1945, with its amendments. There is no established system for monitoring the Physician’s samples as it generally moves from medical representatives to patients via medical professionals. Fixed dose combinations are approved by Drug Controller General of India without proper dose schedule and indications. Metered dose inhaler is presented without dose counter, so that user cannot read how many doses remain. The capacity of CDSCO/the licensing authority/ controlling authority at both national and state level need to be matched with Pharmaceutical Industry in term of man power, infrastructure and training to provide safe and effective drugs to the patients. In the present review, those areas have been highlighted along with some possible solutions such as more stringency and uniformity in drug regulatory policies, use of software to identify duplicate and misbranded medicines, speedy functioning of drug regulatory authorities etc.

Authors and Affiliations

Dipak Kumar Mal, Samrat Chakraborty, Biswajit Mukherjee

Keywords

Related Articles

INSIDE STORY FOR REVIEW OF AN ABBREVIATED NEW DRUG APPLICATION

ANDA constitutes an important submission for marketing authorization of generic drugs. The FDA has recently mandated an electronic submission in the form of eCTD for the same. ANDA application is quite complex with respe...

UNDERSTANDING TECHNICAL BARRIERS TO TRADE AGREEMENT

Signing of formation of World Trade Organization has transformed trade, services and intellectual property into a mutual, predictable exchange of trade and intellectual property protection among member countries. Countri...

FEEBLE REGULATORY AFFAIRS WEAKEN THE BACKBONE OF INDIAN DRUG INDUSTRIES

India is emerging as a global outsourcing power house in almost all fields including Drugs and Pharmaceutical sector. Now it becomes a hub to conduct clinical trials and contract researches. Pharmaceutical industry curre...

Regulatory requirements for Vaccine registration in United States

Vaccination is one among the foremost cost-efficient health interventions out available, saving a lot of individuals from illness, incapacity, and death annually. No alternative countermeasures are effective in reducing...

FORMULATION AND IN-VITRO EVALUATION OF HOLLOW MICROSPHERES OF GLIPIZIDE

Present work involves attempts to improve floating time of glipizide by formulation of hollow microspheres incorporating Glyceryl Monostearate and acryflow. The floating microspheres were evaluated for percentage yield,...

Download PDF file
  • EP ID EP343047
  • DOI -
  • Views 110
  • Downloads 0

How To Cite

Dipak Kumar Mal, Samrat Chakraborty, Biswajit Mukherjee (2014). FEEBLE REGULATORY AFFAIRS WEAKEN THE BACKBONE OF INDIAN DRUG INDUSTRIES. International Journal of Drug Regulatory Affairs, 2(4), 1-13. https://europub.co.uk./articles/-A-343047