Healthcare related laws of India are very old and they have not kept
pace with the contemporary requirements. In an online world,
traditional laws are more hindered than solution. This is the
reason why we need to amend or even repeal the same and substitute
them with appropriate techno legal laws. In one such initiative the
Central Drugs Standards Control Organisation (CDSCO) is working
towards drafting a new Drugs and Cosmetics Act, 2016 and a Medical
Devices Act, 2016.
Medicines and medical
devices are in existence for many years. Information and
communication technology (ICT) has changed the way medicines and
medical devices were sold in old times. Even medical devices have
assumed a totally different identity with the introduction of smart
technology and artificial intelligence. Now smart gadgets have
connected individuals with hospitals, clinics and family doctors in a
24 x 7 x 365 mode. Health related data and information is available
in real time to both doctors and the patients that has significantly
improved the health of patients as remedial measures can be taken
well in advance based on the data provided by smart e-health gadgets.
However, laws in India
are lagging far behind and they are not compatible with the concepts
like e-health, telemedicine, m-health, online pharmacies, etc.
Further, India has still not enacted necessary dedicated laws for
cyber
security, privacy,
data
protection (pdf), online
pharmacies, Ayurvedic
preparations, etc without which Indian healthcare industry
cannot grow and survive. Indian e-health and medical device
manufacturers are also not complying with techno legal requirements
like cyber
law due diligence (pdf), encryption
laws, etc. If we wish to incorporate e-health,
m-health
and telemedicine
into a smart
city model, then we have additional techno legal
compliances that must be ensured.
Indian government is in
the process of removing redundant and outdated laws and enacting new
one as per contemporary requirements. Healthcare industry is also on
the priority list of Indian government for legislative business. For
instance, the Central Drugs Standards Control Organisation (CDSCO) is
working towards drafting a new Drugs and Cosmetics Act, 2016 and a
Medical Devices Act, 2016. The move follows after the ministry of
health and family welfare initiated steps to revisit the D&C Act
1940 and Rules 1945. The objective of this step is to enact
contemporary laws that can ensure safety, efficacy and quality of
drugs and medical devices.
The director (Admin) of
Central Drugs Standards Control Organisation (CDSCO) has on June 6,
2016 asked
all state drugs controllers to give feedback based on their
experience within 15 days from the said notice. There have been
several transformations like new brands, biologicals and biotech
drugs besides the fixed dose combinations that need a set of
dedicated rules. These rules are also relevant keeping in mind the
regulatory requirements of different countries where Indian medicines
and medical and healthcare products are exported.
For instance, recently
the United States Food and Drug Administration (U.S. FDA) issued an
Import
Alert 66-40 (pdf) titled Detention Without Physical
Examination Of Drugs From Firms Which Have Not Met Drug GMPs. This
alert deals with detention
without physical examination of drugs from firms which
have not met drug good manufacturing practices (GMPs). Many Indian
pharmaceutical companies have been listed
on this alert and import from them has been banned. In fact, Lupin
has recalled
9,210 bottles of Suprax drugs for failure to pass purity test.
Border enforcement of
intellectual property rights (IPRs) by countries including European
Union has also posed problem for Indian pharmaceutical and
healthcare companies. EU and India even decided
to sign a letter of understanding to protect off patent generic drug
consignments. Further, due to policy decisions of United States,
Novartis
AG’s heart drug Diovan was also kept out of patients
reach. This is despite the fact that Indian patent law is in
conformity
with WTO and international obligations. Expiring medicine Patents can
boost
pharmaceutical business and e-commerce as the generic pharmaceutical
companies can provide affordable drugs in large quantity.
The Drugs
and Cosmetics Act & Rules 2016 will try to ensure compliance with
some of these issues by the Indian pharma industry. There is also the
introduction of Central Licensing Authority (CLA) along with State
Licensing Authority (SLA) and Central Licensing Approval Authority
(CLAA) for Schedule III drugs in the last year's Amendment Bill. The
new regulations may also cover the Uniform Code for Pharma Marketing,
Formation of Task Force to formulate bulk drug policy, medical
devices policy, creation of price monitoring and resource units in
the state drugs control department.
