KEY REGULATIONS AND POLICIES

The following description is a summary of certain sector specific laws, regulations, rules, notifications, circulars and policies
in India, which are applicable to us. The information detailed in this chapter, is based on the current provisions of key statutes,
rules, regulations, notifications, memorandums, circulars and policies, as amended, and are subject to future amendments,
changes and/or modifications. The information detailed in this section has been obtained from publications available in the
public domain. The regulations and their descriptions set out below may not be exhaustive and are only intended to provide
general information to the bidders and are neither designed nor intended to substitute for professional legal advice. Judicial
and administrative interpretations are subject to modification or clarification by subsequent legislative, judicial or
administrative decisions.

Under the provisions of various Central Government and State Government statutes and legislations, our Company is required
to obtain and regularly renew certain licenses or registrations and to seek statutory permissions to conduct our business and
operations in India. For information regarding regulatory approvals required by our Company, see “Government and Other
Approvals” on page 312.

INDIAN LAWS APPLICABLE TO OUR COMPANY
Drugs (Control) Act, 1950 (“Drugs Act”)

The Drugs Act provides for control of sale, supply, and distribution of drugs. Under the Drugs Act, any drug may be declared
by the Central Government to be a drug within its purview. The authorities may also prohibit the disposal or direct the sale of
any specified drug.

Drugs and Cosmetics Act, 1940 (“DCA”) and the Drugs and Cosmetics Rules, 1945 (“DCA Rules”)

The DCA regulates the import, manufacture, distribution and sale of drugs and cosmetics and prohibits the import, manufacture
and sale of certain drugs and cosmetics which are, inter alia, misbranded, adulterated, spurious or harmful. The DCA Rules
specify the requirement of a license for the manufacture or sale of any drug or cosmetic including for the purpose of
examination, testing or analysis. It further mandates that every person holding a license must keep and maintain such records,
registers and other documents as may be prescribed which may be subject to inspection by the relevant authorities.

The Cosmetic Rules, 2020 (“Cosmetic Rules”)

The Cosmetic Rules governs the regulatory requirements for the manufacture, testing, labeling, import, registration,
distribution, and sale of cosmetics. As per the 2020 Rules, a “new cosmetic” refers to a cosmetic that contains a novel ingredient
that has not been used anywhere in the world or is not recognized for use in cosmetics in any national or international literature.
The Cosmetic Rules provide importers of new cosmetic to seek approval by making an application to Central Licensing
Authority (CLSA) before registration of import of new cosmetics into India. If the manufacturer or the importer fails to comply
with any conditions of the registration, then the CLSA may after giving an opportunity of being heard regarding why such order
should not be passed, can pass an order in writing directing suspension or cancellation of registration for a certain period as it
may deem fit either wholly or in respect to some cosmetics.

Drugs (Prices Control) Order, 2013 (“DPCO”)

The DPCO prescribes inter alia the ceiling price of scheduled formulations, retail price of a new drug for existing manufacturers
of scheduled formulations, maximum retail price of scheduled formulations. Under the DPCO, the Central Government may
issue directions to the manufacturers of active pharmaceutical ingredients or bulk drugs and formulations to increase production
or sell such active pharmaceutical ingredient or bulk drug to such manufacturers of formulations and direct the formulators to
sell the formulations to institutions, hospitals or any agency. The DPCO procedures for fixing the ceiling price of scheduled
formulations of specified strengths or dosages, retail price of new drug for existing manufacturers of scheduled formulations,
method of implementation of prices fixed by Central Government and penalties for contravention of its provisions. The National
Pharmaceutical Pricing Authority vide Notification dated March 31, 2020 in pursuance of Notification No. SO 648(E), dated
February 11, 2020, stated that all medical devices shall be governed under the provisions of the Drugs (Prices Control) Order,
2013 (DPCO, 2013) with effect from April 1, 2020

The Narcotic Drugs and Psychotropic Substances Act, 1985 (“NDPS Act”)

The NDPS Acct is a legal framework which seeks to control and regulate operations relating to narcotic drugs and psychotropic
substances. It prohibits, inter alia, the cultivation, production, manufacture, possession, sale, purchase, transportation,
warehousing, consumption, inter-state movement, transhipment and import and export of narcotic drugs and psychotropic
substances, except for medical or scientific purposes. It also controls and regulates controlled substances which can be used in
the manufacturing of narcotic drugs and psychotropic substances. Offences under the NDPS Act are related to violations of the
various prohibitions imposed under the NDPS Act, punishable by both imprisonment and monetary fines.

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