This is the umbrella legislation which deals with regulation of drugs and medical devices in India. It is from Section 12 of this Act that the Central Government derives the power to make rules and as a result the Drugs and Cosmetics Rules, 1945 were formulated. https://www.rickychopra.co/

1. Laws Regulating Drugs
and Medical Devices
:Mr. Ricky Chopra
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2. Introduction
The Drugs and Cosmetics Act,
1940
India has the 4th largest market for drugs and
medical devices in Asia. The industry has been
predicted to grow to be a $ 50 billion industry in less than
5 years by 2025. Not only this, Serum Institute of India is the
largest manufacturer of vaccines in terms of capacity.
Evidently, an industry with such a large potential is unlikely to be left
unregulated by the legislature. As a result, there is a nuanced regulatory
framework in India to govern the production, marketing, distribution and use of
all kinds of medical devices and drugs. The central umbrella
legislation for the same is the Drugs and Cosmetics Act, 1940. All surrounding
legislations, like the Drugs and Cosmetics Rules, 1945 have been formulated
by virtue of powers vested in the Central Government under the Act of 1940.
The Ministry of Health and Family Welfareis the nodal agency under the
Central government which oversees the effective implementation of these
regulations.
This is the umbrella legislation which deals with regulation of drugs and
medical devices in India. It is from Section 12 of this Act that the Central
Government derives the power to make rules and as a result the Drugs
and Cosmetics Rules, 1945 were formulated. Section 5 of the Act gives
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power to the Central Government to constitute a Drugs Technical Advisory
Board (DTAB) which shall be responsible for assisting both the Central as
well as the State Governments for technical matters in implementation of
the Act and the rules.
The second schedule to the Act prescribes standard quality to which drugs
must comply in order to be fit for the Indian market. Section 10 of the Act
imposes a restriction on import of drugs which are not of standard quality,
drugs which are spurious, adulterated and misbranded.
The Act provides for Inspectors under Section 21 and mentions that they
shall be deemed to be public servants. They have powers to enter any
premises, stop any vehicle, take any sample for testing, call for record of
any documents, register etc.
The Act also has a special section, Chapter IV-A dedicated exclusively for
Ayurvedic, Siddha and Unani medicines.
Most importantly, the Act provides for contraventions. Section 27 of the Act
provides any person who is breach of conditions relating to manufacture,
sale or distribution of the drugs or engages in any of these activities without
a valid license shall be liable for imprisonment for a period not less than 10
years along with a fine of amount not less than 10 lakh rupees or three time
the value of the drugs confiscated, whichever is higher. However, Section
32B also gives a respite in the form of option for compounding of less grave
offences by payment of credit to the Central or the State Government as
the case may be. Lastly, Section 36AE entitles the wrongdoer to prefer an
appeal to the concerned High Court. Section 36 AD also states that for the
purposes of this Act, the Special Courts constituted thereunder shall be
deemed to be Court of Sessions under the Code of Criminal procedure,
1973 and shall have all the powers vested in such criminal courts.

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Contrary to the brief and succinct Drugs and
Cosmetics Act, 1940, the Drugs and Cosmetics Rules, 1945
are much more detailed and nuanced. They provide guidelines
for each and every aspect of drugs and devices, ranging from their
manufacture, import, development of drugs, their packing storage, and
labelling, to the procedure for clinical trials for vaccines.
The rules provide for a Central Licensing Authority, which post shall be held
by the Drugs Controller general of India (DCGI). It is the nodal authority for
approvals and authorizations under the rules. The DCGI is a part of the Cen-
tral Drugs Standard Controls Organisation (CDSCO).
It provides for the constitution of a Central Drugs laboratory which shall be
vested with the power to test samples for evaluating their suitability for
grant of license for manufacturing etc. Schedule X of the rules lay out the
detailed procedure for import of drugs and Schedule Y of the Act lays out a
detailed framework for clinical trials for drugs. The framework provides for
manner of application, the eligibility criteria, the fee for licenses, conditions
for granting of the license, the time periods for the procedure, and appeals
in case the entities are not satisfied with the decision of the licensing au-
thority etc.
The Rules also provide for import and storage of homeopathic medicines.
It provides the standards for use not just for humans but also those used for
veterinary purposes. The drugs regulated under the Act and the rules cover
all kinds of drugs whether used for prevention, diagnosis or treatment of a
disease or disorder.
The Drugs and Cosmetics
Rules, 1945

5. The Medical devices Rules, 2017 provide for four categories
of medical devices- Class A, B, C and D devices. Class A medical
devices are low risk devices, Class B devices are low to moderate risk
devices, Class C devices are moderate to high risk devices and Class D
devices are high risk devices. The Act provides for granting registrations and
licenses for testing, manufacturing, import, sale, distribution, stocking or offer
for selling the classified medical devices, testing clinical performance of medi-
cal devices etc. The medical devices are required to conform to the standards
set by the Bureau of Indian Standards under Section 3 of the Bureau of Indian
Standards Act, 1985.
Just like the Drugs and Cosmetics Act had inspectors, the Medical Devices
Rules, 2017 have Medical Device Testing officers. They have the authority to
seize documents, confiscate medical devices, test and evaluate the sample of
medical device that has been sent to them etc.
Recently, the Medical Devices (Amendment) Rules, 2020 were also notified
with a newly incorporated chapter that talks about those medical devices that
are required to be registered and about the procedure to procure the approval
under the original rules.
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The Medical Devices
Rules, 2017

6. On February 11, 2020 the Ministry of Health and
family Welfare issued a notification, bringing medical
devices within the definition of “drugs” under the Drugs and
Medical Devices Act, 1940. It also overhauled the definition of drugs
under section 3 (b) (iv) of the Drugs Cosmetics Act, 1940 to give effect
to the amendment notification. Additionally, registration of all kinds of drugs
has been mandatory. Prior to this, it was unclear for which drugs registration
was mandatory and for which it wasn’t mandatory. The new rules also
prescribe that all medical devices henceforth manufactured must comply with
the ISO standard 13485.
These changes were brought about after a well thought out decision and
consultation with the public by virtue of draft rules which were circulated in
October 2019. Moreover, enough time has been given for medical devices to
be registered, that is, a time period of 18 months has been given from the date
of notification. While new devices may get their license and registration as an
when they are produced, the existing devices which were exempt from
registration under the erstwhile regulations have time until July 2021 to get
their devices registered.
As far as manufacturers, importers and sellers of medical devices are con-
cerned, a breathing period of 30 months has been given by way of exemption
from registration for Class A and B devices, a period of 40 months for Class C
and D devices.
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Recent Developments

7. Ricky Chopra International Counsels is a leading full-service law firm
in India with a specialized practice area dedicated to the medical sector.
Our experienced group of lawyers have several years of experience in giving
cutting edge to advice to our clients in the medical sector, both in India as well
as globally. Senior leaders of the firm have experience of appearing before a
variety of tribunals and regulatory authorities including the CDSCO. Whether it
is procuring a license for manufacturing a drug, approval for clinical trials for
developing a potential vaccine or getting sanctions for importing a drug for
sale in India, our team can assist you in every leg of the process.
The amendments brought about in 2020 have certainly been salutary. They
not only bring about the much needed clarity in respect of registration for
medical devices, but by making registration for every medical device manda-
tory, it has benefitted the consumers as manufacturers and distributors will
have to keep a check on the quality of their products. The provision for proper
display of date of manufacture, import and expiry on the label also assists the
consumers in determining whether the particular device is safe for their use or
not.
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Ricky Chopra International
Counsels’ Practice in the
Medical Devices Sector
Conclusion

8. With the onset of the COVID-19 pandemic and other emerging bacteria and
viruses, the pharmaceutical sector has come to become one of the most
crucial sectors affecting the population directly. To leave the matters to State
Government or to the stakeholders themselves for self-regulation wouldn’t
prove to be a viable solution. Therefore, the amendments have come about in
a timely manner to make India well-equipped to deal with future challenges in
the medical industry.
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