Context: Recently, Competition Commission of India (CCI) has released a report titled ‘Market Study on the Pharmaceutical Sector in India: Key Findings and Observations’.

• Under which it said to address 'information asymmetry' in pharma space National digital drugs databank will be setup.

Key Points

• A national digital drugs databank will help in addressing “information asymmetry” as well as provide key inputs in mapping the regulatory needs of different states, according to a pharmaceutical sector study conducted by the Competition Commission of India.
• The fair trade watchdog, which works on ways to foster competition and curb anti-competitive practices, in the market study found that brand competition overrides price competition in the domestic market where generic formulations are marketed with distinct brand names.
• Generic drugs play an important role in bringing down drug prices, thereby reducing healthcare costs and improving access.
• In India, generics dominate pharmaceutical sales, and the generic manufacturing within each molecule/formulation market is characterised by the presence of multiple manufacturers.

Key findings of the report

• Pharmaceutical Sector: Globally, India ranks 3rd in terms of pharmaceutical production by volume and 13th by value.
• Out of Pocket Expenditure(OOPE): Pharmaceuticals including generic drugs account for about 43.2%  of out of pocket healthcare expenditure in India and about 62.7% of the total health spending in the country.
• Generic Drugs: India is the largest supplier of generic drugs globally. However, the market for generic drugs is driven by brand competition instead of price competition despite such drugs being functionally and chemically identical. 

Note: Generic drugs are chemically identical to drugs that once had patent protection.

• Online Pharmacies: The share of online pharmacies stood at 2.8% in 2018. The sector’s reach has now expanded during the pandemic to 8.8 million households from 3.5 million households prior to the pandemic.

Key suggestions given by the report

• Necessary regulations should be enforced to safeguard patient privacy and protect sensitive personal medical data.
• Data and digital technology can be used effectively to improve access to and efficiency of healthcare delivery.
• Online pharmacies should adopt self-regulatory measures in the areas of collection, use, sharing of data and privacy.
• Effective price competition in generics can benefit consumers and improve access to affordable healthcare. 
• National Digital Drugs Databank should be created and made available to regulators, industry, physicians and consumers to address information asymmetry in the sector.
• CDSCO (Central Drugs Standard Control Organisation) should ensure uniform and consistent application of quality standards.
• There should be an increase in the frequency of testing of drugs and in the capacity of drug testing labs.

Generic Medicine

• A generic drug is a pharmaceutical drug that contains the same chemical substance as a drug that was originally protected by patents.
• Generic drugs are allowed for sale after the patents on the original drugs expire.
• Because the active chemical substance is the same, the medical profile of generics is believed to be equivalent in performance.
• A generic drug has the same active pharmaceutical ingredient (API) as the original, but it may differ in some characteristics such as the manufacturing process, formulation, excipients, color, taste, and packaging.
• The dosage, composition, method of intake, benefits, quality, and even side effects of generic medicines are similar to the brand-name version of the drugs.

API

• An active pharmaceutical ingredient (API), is the key ingredient of a drug or medicine, which lends it the desired therapeutic effect or produces the intended pharmacological activity. For example, paracetamol is a bulk drug, which acts against pain.
• API, also called as Bulk Drugs are mixed with binding agents or solvents to prepare the finished pharmaceutical product, i.e. a paracetamol tablet, capsule or syrup, which is consumed by the patient.

By: Shubham Tiwari