Introduction

India is widely regarded as the pharmacy of the world because a significant percentage of the world’s medicines are manufactured in India. The manufacturing of medicines in India offers valuable cost advantage that is backed by world class best practices for quality assurances.

Most important laws

• The Drugs and Cosmetics Act, 1940 and Rules framed under the Act regulates the quality of medicines that are imported, manufactured, distributed and sold in India.
• The Drugs (Prices Control) Order, 2013 regulates the price of all medicines sold in India.
• The Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954 and Rules governs advertisement and therapeutic claims relating to medicine.
• The Competition Act, 2002 regulates anti-competitive behaviour amongst manufacturers, supply chain and other stake holders.
• The Consumer Protection Act, 1986 / The Consumer Protection Act, 2019 regulates unfair trade practices and restrictive trade practices, and imposes product liability obligations for manufacturing defects in product that cause harm.
• The Patents Act, 1970 provides for exclusivity over innovative medicines, but does not allow ever-greening.
• The Trade Marks Act, 1999 provides protection to brand name for the medicines, in addition to common law protection for passing-off of trade dress and packaging.
• Numerous environmental laws prescribe that an environmental impact assessment must be undertaken prior to establishment of industries, limit industry expansion and impose strict conditions on waste management especially for hazardous waste and solid waste.

Key things to remember

• Indian pharmaceutical market is essentially a brand driven market. Due to certain policy decisions taken by the government, product patents for medicines were delayed and introduced only in 2005. Therefore, the market has evolved into a brand driven market. Hence, it is crucial that the brands under which products are launched in India are protected by a trade mark. In a licensing arrangement, it is always prudent to retain ownership of the brand under which the drug will be marketed by the licensee.
• India does not have universal health insurance. In effect, this means that treatment cost is largely self funded by Indians directly or by using insurance coverage t obtained privately. Therefore, Pricing strategy is critical for marketing and selling medicine in India .
• Drugs are considered to be essential commodities, and their prices and distribution is strictly controlled. This means that government can fix prices of drugs and all importers/manufacturers are required comply and sell as per the fixed price. Though the powers of the government to fix prices of medicines are limited to those drugs which are part of National List of Essential Medicines, but in the public interest, such powers can be exercised for any drug.

Important sub-segments and related industries

• Bio-pharma – The
• Specialty products
• Formulations
• API & Intermediates
• Narcotic Drugs, Psychoactive Substances & Pre-cursor chemicals
• Research & Development
• Testing
• Pharmacovigliance