FEEBLE REGULATORY AFFAIRS WEAKEN THE BACKBONE OF INDIAN DRUG INDUSTRIES

  • Mal Dipak Kumar Contai Polytechnic, Purba Medinipur, West Bengal, India.
  • Samrat Chakraborty Department of Pharmaceutical Technology, Jadavpur University, Kolkata 700032, India
  • Biswajit Mukherjee Department of Pharmaceutical Technology, Jadavpur University, Kolkata 700032, India

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.
 

Keywords: Indian pharmaceutical industry, Patent, Clinical trials, Inhaler, Fixed dose combinations.

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Author Biographies

Mal Dipak Kumar, Contai Polytechnic, Purba Medinipur, West Bengal, India.

Contai Polytechnic, Purba Medinipur, West Bengal, India.

Samrat Chakraborty, Department of Pharmaceutical Technology, Jadavpur University, Kolkata 700032, India

Department of Pharmaceutical Technology, Jadavpur University, Kolkata 700032, India

Biswajit Mukherjee, Department of Pharmaceutical Technology, Jadavpur University, Kolkata 700032, India

Department of Pharmaceutical Technology, Jadavpur University, Kolkata 700032, India

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How to Cite
Kumar, M. D., S. Chakraborty, and B. Mukherjee. “FEEBLE REGULATORY AFFAIRS WEAKEN THE BACKBONE OF INDIAN DRUG INDUSTRIES”. International Journal of Drug Regulatory Affairs, Vol. 2, no. 4, Dec. 2018, pp. 1-13, doi:https://doi.org/10.22270/ijdra.v2i4.10.