The State of Drug Manufacturing in India - Pharmaceutical Technology

Latest Issue

Latest Issue
PharmTech Europe

The State of Drug Manufacturing in India
Siegfried Schmitt, principal consultant at PAREXEL, discusses the state of drug manufacturing in India.

PTSM: Pharmaceutical Technology Sourcing and Management
Volume 10, Issue 2

Q. Some recent high-profile cases of quality issues at Indian manufacturers have given reason to examine manufacturers more closely. What are some issues that should be considered?

A. Indian manufacturers of APIs and drug products have been in the news for some time now, mostly under negative headlines. This fact may lead some to believe that there is something fundamentally wrong with them. Before jumping to conclusions, however, we must look closer at the issues at hand. The move east
Continued cost pressures and increased outsourcing in recent decades resulted in many European and US companies sourcing their APIs from countries, such as India and China, which have lower labor costs. India was an obvious choice for its large pool of skilled and unskilled labor, plus an existing chemical and pharmaceutical industry. Currently, between 50-70% of APIs imported in the US and Europe are sourced from India (1). This is why European and US regulators have conducted many inspections in India, and why FDA even established permanent offices in Mumbai and New Delhi (2). This high volume of inspections has resulted in a large number of findings.

From APIs to drug products
Profit margins for drug products are significantly higher than those for APIs, and several Indian companies have decided to capture their share of this lucrative market, particularly US and EU markets. Regulatory requirements for drug products, especially sterile ones, are much more demanding than those for APIs, and this is where many Indian drug manufacturers face their most serious problems. Warning letters and import alerts have been issued to several leading Indian pharma companies, triggering much of the negative publicity previously noted (3). It is important to note that EU inspection reports are only made public if requested under Freedom of Information legislation from the National Competent Authority, which conducts the inspection.

Data integrity concerns

Although inspection findings in India reflect those cited elsewhere, what sets them apart is that often data-integrity issues are being singled out in an inspection (4). Therefore, one might conclude that data falsification is rife. Though there is no denying that data-handling irregularities have been detected, there has not always been a malicious intention behind them. In several cases, there has been a misguided belief that data should look good. However, such data manipulation or data invention still constitutes fraud, irrespective of a person’s intention.

Ultimately, Indian drug manufacturers are in the spotlight because of non-compliance issues, such as insufficient environmental monitoring or a lack of documented evidence. Many US- and EU-based companies, however, often times garner attention for the same reasons. This fact is of real concern: why does the mature pharmaceutical industry in Europe and the US still struggle to comply with applicable regulations? If anything, the expectation is that there should be a much higher level of compliance among US and EU companies compared with their Indian counterparts.

Clearly, these issues must be resolved by all Indian companies concerned, just as everywhere else. As remediation efforts are under way, we hope to soon see more positive headlines coming from that part of the world.

1. S. Bennett, Specialty Chemicals Magazine (June 2013),, accessed Nov. 6, 2013.
2. A. Lal,  “FDA In India: Going Global, Coming Home,” accessed Nov. 6, 2013.
3. FDA, Import Alerts,, accessed Nov. 6, 2013.
4. “MHRA Cites Wockhardt Plant for GMP Noncompliance,,, accessed Nov. 6, 2013.

Siegfried Schmitt




blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
| Weekly

What role should the US government play in the current Ebola outbreak?
Finance development of drugs to treat/prevent disease.
Oversee medical treatment of patients in the US.
Provide treatment for patients globally.
All of the above.
No government involvement in patient treatment or drug development.
Finance development of drugs to treat/prevent disease.
Oversee medical treatment of patients in the US.
Provide treatment for patients globally.
All of the above.
No government involvement in patient treatment or drug development.
Jim Miller Outsourcing Outlook Jim MillerOutside Looking In
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerAdvances in Large-Scale Heterocyclic Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler New Era for Generic Drugs
Sean Milmo European Regulatory WatchSean MilmoTackling Drug Shortages
New Congress to Tackle Health Reform, Biomedical Innovation, Tax Policy
Combination Products Challenge Biopharma Manufacturers
Seven Steps to Solving Tabletting and Tooling ProblemsStep 1: Clean
Legislators Urge Added Incentives for Ebola Drug Development
FDA Reorganization to Promote Drug Quality
Source: PTSM: Pharmaceutical Technology Sourcing and Management,
Click here