Monday, 26 August 2013

DECLINE IN NEW DRUG LAUNCH :MYTH OR REALITY

As per current scenario theres is wide increase pharmaceutical research and development ,times,cost and spending but there are concerns that these efforts are not reflected in the no of new drugs being brought to the market it is widely reported that there is a decline in no of new drugs in market .well there can be various reasons for that ,but as per the heading i will talk with facts .
The exact no of drugs approved till now in india 
The exact no of drugs that are approved till now in india are given as 
From 1971 - AUGUST 2013 
Total no of drugs approved from 1971 to August 2013
YEAR
NO OF DRUGS APPROVED
1971-1981
351
1982-1992
321
1993-1998
157
1999
23
2000
28
2001
41
2002
56
2003
39
2004
76
2005
122
2006
161
2007
188
2008
264
2009
208
2010
221
2011
79
2012
43
August 2013
23
TOTAL NO OF DRUGS TILL NOW
2401

well this as this data shows there is a decline in no of new drugs approved in year 2011,12 and if we talk about year 2013 it is also dont have a hope of crossing the no hundred 

it is clearly visible from the above data that how the new drug development has declined from year 2010 India’s population is just over 1.2 billion at present and projected to rise to 1.7 billion by 2050 and India will become the world’s most populous country.This projection shows that the demand of drugs will rise in coming years. There is a need, at national level to acquire an expertise in the field of R&D and to develop the technology to build up capacity in innovation and production of the drugs to ensure that essential drugs at affordable prices are available to the vast population. The reasons for this downfall can be given as follows
THE NEW GOVERNMENT POLICIES
The new government policies are widely affecting the new drug launch policies of the company. the total focus of the government is on the generic drugs but we should must not neglect the fact that new disease needs new drug and development of new drugs is the only policy which can help us to gain control over wide spreading diseases.
THE NEW PATENT REGIME IN INDIA
While the large firms are gearing up to face the challenges of the patent regime, the small scale segment of the Indian pharmaceutical industry suffers from various inadequacies including lack of expertise, training and finance for technological upgradation and adoption of good manufacturing practices (GMP) to meet global quality standards; limited exposure and expertise on IPR issues; limited adoption of information technology (IT) techniques in production and processes.
THE LEAST INVESTMENT IN R&D SECTOR
The total no of investment in the new drug development has also decreased these years ow or negligible R&D  expenditure which affects the ability of SMEs to offer innovative solutions; and the inability of SMEs to access finance on easy terms for import of capital goods and undertaking advertising and marketing activities.
THE DRUG PRICE CONTROL 
price control tends to reduce the market shares of both domestic and foreign companies, and this factor by
itself should not cause the relative share of foreign companies to decline. At the same time, it needs to be noted that in certain ways, domestic companies are able to offset to some extent the adverse effect of price control on their market share.

Most of the MNCs pharma companies have stopped launching latest products in India after 1995 though they have been introducing them in other parts of the world. 
Overall, it seems there are no immediate danger of price rise due to the new patent system, especially because much of these patented applications/drugs are very similar to the off-patent drugs and offer possibilities of substitution. However, there may be some medium to long run price effects of the new patent system, when far superior patent protected drugs come into the market, whether from Indian or foreign firms. And, this may result in significant loss of consumer welfare.

Table shows number of Anatomical Therapeutic Chemical (ATC) groups Approvals (1999-2011)

Anatomical Therapeutic Chemical (ATC) groups
Number of Approvals
A - Alimentary tract and metabolism
192
B - Blood and blood forming organs
39
C - Cardiovascular system
186
D – Dermatologicals
108
G - Genito urinary system and sex hormones
56
H - Systemic hormonal preparations (excluding sex hormones and insulins
10
J - Antiinfectives for systemic use
204
L - Antineoplastic and immunomodulating agent
102
M - Musculo-skeletal system
145
N - Nervous system
232
P - Antiparasitic products, insecticides and repellents
20
R - Respiratory system
115
S - Sensory organs
74
V – Various
23


THE FOCUS ON GENERICS 
One man named AAMIR KHAN just showed on his show how generics are important and rest of india started believing  his words well i am not saying that generics are not important but the fact is that you can never kill innovation on the name of generics and now a days even the establish companies are looking through the option of generics by sacrificing there  research

THERE ARE MANY MORE COUNTRIES WHICH DON'T RECOGNIZE PATENT 
Countries like south korea Switzerland and Italy don't even have patent law till 1960 and 70 but they have to introduce the law becoz there local investors were looking forward to get their patent by other countries which caused sudden shortage of new drugs throughout the countries.

well these were my views. As in my last post also i didn suggested any of the solution  and same is also here becoz i want to know the suggested answers from my viewers .......... so please come forward and answer the questions