Category Archives: Clinical Research

Archives

While there is still a row going on about the size of pictorial warnings on the cigarette packs, a new study claims that warnings in images as well as text are more likely to motivate people (especially young adults) to quit smoking, making them understand the various dangers and the effects of smoking.

According to a new research by the Washington State University, Vancouver, published online in the Annals of Behavioral Medicine, pictorial warnings or warnings with images and texts are more effective and influential in quitting smoking.

Although more and more evidence support graphic warnings in discouraging smokers, there has been very less research to show how smokers learn from the warnings, generally people with rotting teeth, facial scars and people dying in hospital beds. Continue reading

The ‘Make in India’ campaign by Prime Minister Narendra Modi has 25 sectors in focus including Pharmaceuticals and Chemical sector. This may proven to be a booster dose to the Pharmaceutical Manufacturing Industry.

MII x

The Make India campaign will result in attracting investment from foreign markets. The government has already created a dedicated online cell to answer queries from all over the globe. Primarily, the ‘Make In India’ focuses on zero defect and zero effect. In which zero defect means products which are manufactured in India should not be rejected in the overseas market. Zero effect means that the manufacturing should not have any negative impact on the environment. Continue reading

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

Healthcare and literacy

Censuses in India have defined the population growth as – 1891 – 1921, as Stagnant Population, 1921 – 1951, as Steady Growth, 1951 – 1981, as Rapid Growth, 1981 – 2011 High Growth with signs of Slowing down, 2011 – onward, as Controlled Growth which has been used as parameters of measuring many social sciences studies. Current census of 2011 clearly defines the Indian Population as the emerging Super Power in Manpower of the world by 2020 because of the largest segment of the young population, which is of course a transit advantage for the country. Like other censuses this current census 2011 has highlighted the issues like (CSR) declining Child Sex Ratio, higher level of (TFR) Total Fertility Rate, Increased Literacy Rate etc. as controllable measures for the nation.

All of the above classifications do not rule out the fact that the Indian population is growing at an ever expanding level. According to the CIS, world fact book, the Health expenditures in India are     2.4% of GDP (2009) and India ranks 185 in world rankings. Needless to say major Asian countries have moved in the direction of increasing their healthcare expenditures to greater than 2.5%. Continue reading

Reduced production

In the recent economic slowdown where the industrial sector in India has been grossly affected, the Pharmaceutical Industry is no exception. The Pharmaceutical Industry has been facing pressure on the export front because of the ups and downs in the dollar, stricter laws from the US FDA, increase in the generic drug fee of the ANDA dossier, rising manufacturing costs, rising cost of the raw material, pricing pressures (DPCO) and the Pharma MNC’s trying to buy out existing units in Indian and trying to increase their geographic presence.

Even semi regulated markets are in the process of enforcing stricter regulations for exports of medicines from India. Continue reading

As the wise saying goes ” Health is Wealth.” Human health today is of key concern among all. For the betterment of health and well being, everyone needs to safeguard against all possible known and unknown attacks of disease. Medicines help us tackle the existing diseases. However, new medicines are required to tackle unknown diseases. New medicines can only be brought to human use if clinical research is conducted. In the present scenario where clinical research has nearly come to a halt in the country, it goes without saying that healthcare needs of millions are affected. Continue reading

Clinical trials market in India-Will the same pick up in India?

This is the key question with analysts, investors and all stakeholders who have been observing this market in the recent times. The clinical trial industry since the year 2006 has been expected to grow in double digits because of its vast patient population.

However, things have not been bright for the industry particularly since 2009.

Data available at the Clinical trial registry of India has witnessed a step hike in clinical trial registration since it came into inception. On an international level, data at the Clinical trials Gov. site has also captured this aspect. 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

The conventional use of social media is to connect with friends, near and dear ones. This concept exists worldwide. However the western world has been the first to tap the social media to its right use and that is why many good businesses thrive because of the social media. The pharmaceutical industry is no exception to the above rule.

Pharmaceutical industry in the west has picked up the social media for educating its customers i.e. patients and doctors Continue reading