India is the 3rd largest in terms of volume and 13th in terms of value all over the world as we still struggle in terms of quality so in this ppt i show some challenges faced by Indian Pharmaceutical Industry

1. Current RegulatoryChallenges in IndianPharmaceutical Industry
MASTER OF PHARMACY
(DRUG REGULATORY AFFAIRS)
BY
VIKAS RATHEE
80000802005
UNDER THE GUIDANCE OF
Department of Pharmaceutical Sciences
Chaudhary Bansi Lal University
Bhiwani-127021
Mrs. Neelam
Assistant Professor
Supervisior
Dr. Shahbaz Alam
CMD, Meher Pharma Int.
Co-Supervisior

2. Table of Contents :
Aim & Objective
Introduction
Major Bodies Regulating Drugs and Pharma
Key Challenges : Data Integrity, Credibility of Clinical Trial Data, IPR, R&D
Key Issues of Concern : Patent Protection, Lack of Regulatory Data Protection,
Government Price Control, Clinical Trials
Methodology
References

3. AIM : To Study the Current Regulatory Challenges in Indian Pharmaceutical Industry.
Objective :To study
the overview of
regulatory laws and
regulatory
environment in India.
To study the current
regulatory challenges faced
by Indian Pharmaceutical
Industry (lack of access to
resources of CDSCO).
To study the increase
of spurious and
substandard drugs in
Indian market
To study the problems
faced by low scale
Pharmaceutical
Industries.
To study the
transparency of
licensing authority
Lack of price control
(Indian pharmaceutical
companies face high
effective import duties for
active ingredients).

4. INTRODUCTION:
Major Bodies Regulating Drugs and
Pharma:
The principal regulatory bodies entrusted with
the responsibility of ensuring the approval,
production and marketing of quality drugs in
India at reasonable prices are as follows:

7. Data Integrity
Multiple data integrity issues reported by the
investigators include failure to record activities
contemporaneously; document backdating; copying
existing data as new information; re-running
samples to obtain better results; and fabricating or
discarding data

8. Credibility of Clinical Trial Data
India has emerged as the ideal location to conduct clinical trials given its diverse pool of
patients with diverse treatment needs, and access to a large, scientifically skilled,
workforce
Capacity to regulate clinical trials has not kept pace with this growth leading to a number
of reported unethical practices such as: limited patient compensation for adverse events;
approval of drugs without clinical trials; and lapses in informed consent procedures

9. IPR
Patent laws in India compliant with the TRIPS Agreement
Granting of compulsory licenses (CLs) have been contentious
While CLs have been viewed as a necessary evil, in a developing
country, like India, they have also caused grave concerns in the
industry due to the revenue loss that CLs tend to cause

10. R&D
According to the Patent & Trademark Office (drug development and the rest has been on new processes, new
dosage forms and drug delivery PTO) patents granted to Indian pharma companies constitute only 5 per cent for
the new systems
The trade liberalization measures though have attracted foreign investment in pharmaceutical R&D in India in the
form of contract research, collaborative research projects, out-licensing and in-licensing partnerships, the scope for
transfer of technology and joint ownership of technology has been very limited.
Further, the Indian pharmaceutical industry is also witnessing regulatory challenges with respect to uncertainties
over the FDI policy, the new pharmaceutical pricing policy, a uniform code for sales and marketing practices, and
compulsory licensing. These challenges have been slowing down the growth of the industry.

12. Patent protection
India’s legal and regulatory systems pose procedural and substantive barriers at every step
the process, ranging from the impermissible hurdles to patentability posed by Section 3(d)
the India‘s patents act, to the threat of compulsory licensing on specious grounds, to pre-
grant and post-grant opposition proceedings.
Since early 2012, at least fifteen products have had their patent rights undermined in India.
addition, the Government of India is considering issuance of compulsory licenses (CLs)
through a Ministry of Health Committee on the grounds of national emergency; extreme
urgency, and public non-commercial use.

13. Lack of regulatory data protection
The Indian Regulatory Authority relies on test data submitted by originators to another
country when granting marketing approval to follow-on pharmaceutical products.
This indirect reliance results in unfair commercial use prohibited by the World Trade
Organization (WTO)Agreement on Trade-Related Aspects of Intellectual Property Rights
(TRIPS) and discourages the development of new medicines that could meet unmet medical
needs.

14. Government price controls
The Department of Pharmaceuticals (DoP) has proposed an international reference pricing scheme
with a purchasing power parity adjustment for government procured patented medicines and
those patented medicines provided through health insurance.
This proposal would create an unviable government pricing framework and business environment
for medicines whose price levels in India are already low in comparison to other countries. The
Drug Price Control Order (DPCO) 2013 includes a provision discriminating against foreign products
by exempting only indigenous research and development.

15. Clinical trials
New clinical trials were halted after the Indian Ministry of Health and Family Welfare adopted rules that require
broader compensation for participants who claim to have been injured due to a clinical trial. Most recently, the
Drug Controller General of India (DCGI) ordered that, in addition to obtaining written informed consent,
audio-visual recording of the consent of each subject is mandatory in a clinical trial and effective immediately.
Such uncertainty in the regulatory process for clinical trials threatens the overall clinical research environment
in India, as well as the availability of new treatments and vaccines for Indian patents.

16. METHODOLOGY
The mentioned aims and objective will be achieved by literature survey of various
challenges face by the pharmaceutical industries such as Non harmonizdation between
Central and SLA, lack of assurance of approval, lack of acceptance criteria for fixed dose
combination, High import duties on Pharmaceutical API and lack of vigilance on spurious
and substandard rugs. It is high time to radically clean the anarchy in drug regulation in
India for improved quality, safety & efficacy of medicinal product in public health and
welfare. Official website of CDSCO and NPPA will be referred for the requirement and
guidelines for product registration, approval of FDC and for pricing control.

17. Reference :-
Indian Pharmaceutical Industry : Key Challenges [Internet]. Eximbankindia.in. 2019 [cited
11November2019].Availablefrom:https://www.eximbankindia.in/Assets/Dynamic/PDF/Publication-
Resources/ResearchPapers/39file.pdf
Current Regulatory Scenario in India [Internet]. 2019 [cited 11 November 2019]. Available
from:https://www.researchgate.net/publication/278031925
Key issues to be concern [Internet]. Indiaoppi.com. 2019 [cited 11 November 2019].
Availablefrom:https://www.indiaoppi.com/sites/default/files/PDF%20files/Industry%20Challenges_OPPI
%20Document.pdf
Pharmaceutical Regulatory Agencies and Organizations around the World: Scope and Challenges in Drug Development | PharmaTutor
[Internet]. Pharmatutor.org. 2019 [cited 11November2019].Available from: https://www.pharmatutor.org/articles/pharmaceutical-
regulatory-agencies-and-organizations-around-world-scope-challenges-in-drug-development
Introduction to CDSCO [Internet]. Cdsco.gov.in. 2019 [cited 11 November 2019]. Available from:
https://cdsco.gov.in/opencms/opencms/en/About-us/Introduction