The Indian pharmaceutical industry faces several key challenges, including heavy dependence on China for active pharmaceutical ingredients (APIs), where 80% of APIs for the Indian market come from China. Government price controls on drugs limit innovation capabilities of pharmaceutical companies. Rising FDA inspections of Indian facilities and pressure to meet quality standards also pose difficulties. Additionally, 25% of drugs in the domestic Indian market are fake, and India produces 35% of counterfeit drugs globally, indicating a need to address unregulated production. There is also a lack of sufficiently skilled workforce to support GMP-compliant manufacturing despite high numbers of pharma graduates each year.
2. India’s
dependence on
China for APIs
Indian Pharma market is heavily dependent on
China for its API needs. Currently about 80% of the
Indian Pharma Market APIs requirement is fulfilled
by Chinese Pharma Market.
Occasionally there is an increase in API pricing due
to policy changes & geo political reasons.
3. Government
Control on
drug pricing:
The second issue that Indian Pharma is facing today is the
govt. stringent control over the pricing of drugs.
It becomes a hurdle in the innovation capabilities of
Pharma companies
4. USFDA Pressure
& rising number
of Inspections
In 2018 Indian Pharma Manufacturing companies
faced 174 USFDA INSPECTIONS that amounts to
14% of total FDA inspections conducted around the
globe.
As per USFDA report India has 12% of the total
manufacturing units that supply drugs to US & the
ANDA approvals for Indian companies have been
on a consistent rise. Due to all this the FDA
inspections are bound to happen.
5. Fake
Products/Spurious
drugs:
Fake drugs constitute 25% of domestic medicines market in
India: ASSOCHAM
According to WHO 35% of the world’s spurious drugs are
produced in India.
SPURIOUS DRUG PRODUCER
INDIA
UAE
CHINA
THIALAND (4%)
PHILIPINES (2%)
VIETNAM (1%)
CHINA
31%
20%
4%
6. Lack of skilled
work force
India is a place where every year about 225000 Pharma graduates
come up every year.
This leads to lot of GMP issues in manufacturing processes.
