Category Archives: Regulatory


The Indian generic drug industry is the largest supplier of medicines worldwide and US is the largest consumer of the same. One of the leading companies, a leading generic manufacturer which is also the leading supplier of generic medicines to the US has come under the FDA scanner since the last 12 months.  The trigger to the Ranbaxy problems came when Dinesh Thakur , ex-Ranbaxy employee, acted as the whistleblower. The same came out as an action from the FDA when Ranbaxy’s key manufacturing plants in India went on a spree of Imports alerts and 483’s. To add to the problems, even Ranbaxy’s’ US based plants came under the FDA lens.

 The problems were many:

  • Response from the Indian regulated DCGI to the Ranbaxy fiasco came only after the FDA warnings to Ranbaxy
  •  Internal conflict within Ranbaxy between the ex-owners, Malvinder Singh and Diachii Sankyo occupied the front pages of the media Continue reading

The Indian Clinical Research Industry is going through a tough phase. Business in the industry is competitive because of a price war and a very stringent regulatory environment. The market was expected to reach a $ 1 billion in 2010 with a predicted growth rate of 15-20% but because of the prevailing recession and above mentioned factors, the market has yet to reach a size of $800 million in the year 2012-2013. The Industry desperately needs a growth booster. Experts of the industry also need to change the way they think about moving forward. Continue reading

“1400 and still going strong! No certainly it is no sporting landmark in cricket. Neither it is score in nay indoor game. It is the score which signifies the number of pending ANDA applications from the Indian Pharma which are lying on the tables of the USFDA. This not only adds to the cost of healthcare of the consumer in the USA but also prevents the growth of the Indian Pharmaceutical industry.
Most of the Indian Pharma majors who submit their ANAD filings in the USA, have managed to “”file less”” in 2009 as compared to 2008..this backlog on part of the USFDA can potentially delay generic drug competition in both sets of product, both which are already off patent and are available as generics as well as those products which are going to go off patent. This is particularly affecting the growth of all those companies which are export dependent and in turn all those Outsourcing providers particularly CRO’s which are dependent on them. Most of the major Pharma companies are now planning to file their ANDA applications well in advance to account for the delay but the same has not helped them much. Some of the companies whose revenue is at least 33% export dependent have managed to get only 35% of their total approvals cleared at the USFDA.
Non one really benefits from the delayed and pending approvals at the FDA. ”

“Since the last 2 months, there has been a nose diving effects of failures in clinical trials in Phase III in Cancer, biotech and vaccines to name a few. And all names are associated with big names in Pharma and biotech. There has been a spate of failures in the oncology pipelines of Merck, Pfizer and Roche and the decision makers in these companies are trying their level best to convince investors to place their money in clinical development.
This can be an advantageous position for generic drug companies. The generic drug companies with the record breaking patent expiries due post 2010 are likely to benefit from such happenings. However, with drugs like GSK’s Avandia and Rota virus being challenged for various side effects and contamination respectively, it needs to be seen as to “”proven safe drugs over a period of time”” can actually be under the US FDA scanner.
The USFDA is now eyeing off patent small molecule drugs rigorously and adding queries to delay the approval of the ANDA submission under discussion. It is definitely expected that the FDA will even be more rigorous in approving follow on biologics considering that generic drug companies know very little about the manufacturing of the branded biologic product. ”

The European Union and the Indian Government want to place themselves on a mode of Truce. This is with regards to the recent seizure of the Generic drug consignment of a major Indian Pharma by the Dutch authorities at the airport. The consignment was seized on claims by the Dutch authorities that the export was “”illegal”” and the Indian Pharma was “”violating”” the patent laws leading to subsequent “”ban”” of exports of Indian Pharma generic manufacturers.
This has led to a tussle between the EU and the Indian Government wherein India has threatened to “”sue”” the EU at the WTO for the same. However, EU is now declaring a more “”gentle”” stand on this issue and is reassuring the Indian Government that it would take measure to prevent seizures of Indian generic drugs as well as refer not to do so through a legal battle at the World Trade Organization (WTO.).
Veeda Clinical Research is a leading Indian CRO which caters to cost effective bio-equivalence studies for the Global Pharma and biotech industry in a major way.

The drug regulators of various countries believe in maintaining a uniform code of compliance as far as possible across their regulatory framework and in the companies where they conduct audit for measuring and ensuring compliance. No stone is left unturned while examining the records of the companies under the regulatory scanner.
Compliance or adherence to the available regulatory framework is the need of the hour. As compliance issues become mandatory and acquire a more complex dimension, procedures and paths to achieving the same become longer and complicated as well. This is true for both Pharma manufacturing companies as well as CRO’s.
There arises a need to raise perfection standards within companies to ensure compliance with external auditors. This process is not a ONE day affair but an ongoing and routine procedure which needs to be achieved with appropriate monitoring and caution by internal company auditors.
Veeda Clinical Research is an Indian CRO which provides cost effective Bio-Equivalence studies for the drug industry .

The law makers are ensuring that the law is adhered to. With the advent of the recession in the global economy and the influence of generic drug usage in the developed world, there seem to be not many “”choices/options”” for the regulators, particularly the FDA. The FDA has taken up the task of strictly enforcing compliance at both Pharmaceutical manufacturing and the services associated with the same.

The actions initiated have led to the accurate analysis and implementation of the laws related to Bio –equivalence studies as well as the Clinical trials across major and emerging geographical regions in the world. The FDA has also “”revamped’ its website and regularly updates its website as well as well as sends out free email alerts to all its subscribers on a regular basis.
The FDA has taken accountability to as a responsibility to ensure that “”rules’” need for compliance “”are strictly looked into by them. This has been taking an active and pro- active approach in these matters on an ongoing basis.
Pharmaceutical companies and CRO’s all over the world are actively looking at the FDA in terms of compliance on a regular basis.
Veeda Clinical Research is an Indian CRO which provides cost effective Bio-Equivalence studies for the drug industry.

“All approvals and combinations go through the Drug controlling authorities of the respective geographies where filing of the drug applications takes place. The trends from well acclaimed authorities like the USFDA, EU, etc indicate that the same are in process of enforcing stricter compliance to the norms of filing drug applications in their countries. As the times where the economies of the western world are slow, diseases are many and cures are few and Healthcare budgets are “”allocated “”and “”recessed””, pressures are to protect their own industry are very high, it leaves the regulators with anUNSAID call for enforcement of the quality standards of their country on all companies filing their “”generic”” drug applications from outside.
The line of control for Quality assurance and compliance with regulatory norms brings in line to the fact that drug approvals will no longer be easier or less time consuming. This applies to outsourcing providers of the drug industry i.e. CRO’s as well.
The prime and most important market which is showing signs of growth is the Indian CRO market which primarily is and has been moving towards with BA BE Studies.
(Bio Equivalence studies of Generic Drugs)
Veeda Clinical Research is an Indian CRO which provides cost effective Bio-Equivalence studies for the drug industry. ”

“The forces and the law of nature always have the final say on the well being of the earth. It is only the human force which influences the maximum on nature as it is the most “”intellectual”” in terms of the existing living being on the earth. Human beings dominate the ecological balance of nature in a major way without any serious “”Intelligent”” competition.
Scaling the Health care Industry market forces on an identical platform, which are definitely more dynamic than nature, the same is driven by majority of identified and unidentified forces. The”” identified”” /””captured”” forces drive the market in such a way which work towards the creation of scenario dominated by the Policies, Regulators and the policy makers in a major way. Below is an event Dashboard for the week starting on the 15th June 2009 and the events and news which have taken place in the whole week. Policies are driving the market to an extent of 25% of the market Dashboard followed by the Global & Indian Pharma drug trends to an extent of another 25%. Competition and generic drugs occupy the show with another 24 % in totality.

Policies being the most “”intellectual”” part of the dashboard drivers would be the major driving force of the industry. The economic policies for the drugs, their manufacture, their sale and presence in the market is due to a “”set”” policy framework which on a broader level is sequenced and guided by the governments of the countries where the drugs are manufactured. It is the trends of the recessed times to move towards cost effective drug products and all companies of the drug industry are moving in that direction in their own ways and adopted methods. The most cost effective drugs are the off patent drugs/generics/ copy cat versions of branded drugs. Policy drivers in all major countries of the world whether developed or developing are focused towards manufacturing, promoting, selling and consuming generics in a major way. Adhering to the policies formulated by the regulatory agencies of the respective countries is becoming the major objective of the drug industry today. In case the same does not happen in an effective manner, the regulators or the policy makers move towards enforcement of the same in their own way by declarations (as press releases) or website announcements or notices to the concerned.
The drug companies which sell generic products can do so by conducting Bio-equivalence studies with reference to the branded drug. For the same they outsource the studies to CRO’s of their choice which conducts bio-equivalence studies.
Veeda Clinical Research is an Indian CRO with extensive experience in conducting Bio-equivalence studies. ”