Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954 (“Drugs and Magic Remedies Act”)

The Drugs and Magic Remedies Act seeks to control advertisements of drugs in certain cases and prohibits advertisements of
remedies that claim to possess magic qualities and provides for matters connected therewith. For the purposes of this Act,
advertisements include any notice, circular, label, wrapper, or other document or announcement. The schedule to the Act
specifies ailments for which no advertisement is allowed. It prohibits advertisements that misrepresent, make false claims or
mislead.

The Legal Metrology Act, 2009 (“Legal Metrology Act”)

The Legal Metrology Act seeks to establish and enforce standards of weights and measures, regulate trade and commerce in
weights, measures and other goods which are sold or distributed by weight, measure or number and for matters connected
therewith or incidental thereto. The key features of the Legal Metrology Act are (a) appointment of Government approved test
centres for verification of weights and measures; (b) allowing the companies to nominate a person who will be held responsible
for breach of provisions of the Legal Metrology Act. Any non-compliance or violation of the provisions of the Legal Metrology
Act may result in, among others, a monetary penalty on the manufacturer or seizure of goods or imprisonment in certain cases.

National Pharmaceutical Pricing Policy, 2012 (“2012 Policy”)

The National Pharmaceutical” Pricing Policy, 1994 has been replaced by the 2012 Policy and presently seeks to lay down the
principles for pricing of essential drugs specified in the National List of Essential Medicines-2015 declared by the Ministry of
Health and Family Welfare, Government of India and modified from time to time, so as to ensure the availability of such
medicines at reasonable price. The 2012 Policy regulates the prices of the drugs based on their essential nature. Further, the
2012 Policy will regulate the price of formulations only, through market based pricing which is different from the earlier
principle of cost based pricing. Accordingly, the formulations will be priced by fixing a ceiling price and the manufacturers of
such drugs will be free to fix any price equal to or below the ceiling price.

Bureau of Indian Standards Act, 2016 (“BIS Act”)

The BIS Act establishes the Bureau of Indian Standards (BIS) as the national standards body of India. The BIS Act has enabling
provisions for the Government to bring under compulsory certification regime any goods or article of any scheduled industry,
process, system or service which it considers necessary in the public interest or for the protection of human, animal or plant
health, safety of the environment, or prevention of unfair trade practices, or national security.

The Sales Promotion Employees (Conditions of Service) Act, 1976 (“Sales Promotion Act”)

The Sales Promotion Act regulates the conditions of service of sales promotion employees and applies to pharmaceutical
industry. It provides the conditions of appointment, leave and maintenance of registers and other documents of such employees.
The Sales Promotion Act provides monetary penalties for breach of its provisions.

The Food Safety and Standards Act, 2006 (the “FSSA”)

The FSSA was enacted with a view to consolidate the laws relating to food and establish the Food Safety and Standards
Authority of India (“FSSAI”) for setting out scientific standards for articles of food and to regulate their manufacture, storage,
distribution, sale and import to ensure availability of safe and wholesome food for human consumption. The standards
prescribed by the FSSAI include specifications for ingredients, contaminants, pesticide residue, biological hazards and labels.
The FSSA also sets out requirements for licensing and registering food businesses, general principles of food safety, and
responsibilities of the food business operator (“FBO”) and liability of manufacturers and sellers, and adjudication by ‘Food
Safety Appellate Tribunal’.

In exercise of powers under the FSSA, the FSSAI has also framed the Food Safety and Standards Rules, 2011 (the “FSSR”).
The FSSR sets out the enforcement structure and procedures comprising of qualifications and duties of the of ‘commissioner
of food safety’, ‘the food safety officer’ and ‘the food analyst’ and procedures of taking extracts, seizure, sampling and analysis.
The FSSA also lays down penalties for various offences (including food recall procedures). The Food Safety and Standards
(Licensing and Registration of Food Businesses) Regulations, 2011 provides for the conditions and procedures for registration
and licensing process for food business and lays down general requirements to be fulfilled by various FBOs, including petty
FBOs as well as specific requirements to be fulfilled by businesses dealing with certain food products.

In terms of the Food Safety and Standards (Food Recall Procedure) Regulations, 2017, every FBO engaged in manufacturing
of food is required to have a food recall plan. The packaging done by a FBO is required to comply with the Food Safety and
Standards (Packaging) Regulations, 2018, while labelling and display of prepackaged food items must comply with the Food
Safety and Standards (Labelling and Display) Regulations 2020.

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