Given the surge in research and development, amendments to the Patents Act, 1970, and the opening up of the market to foreign drug manufacturers, the pharmaceutical industry has been growing persistently.
It meets around 70% of the country’s demand for bulk drugs, drug intermediates, pharmaceutical formulations, chemicals, tablets, capsules, orals and injectibles. Being one of the key industries supporting the health sector, its regulation assumes critical importance.
New authority in the pipeline
The proliferation of spurious drugs and drugs with identical or similar sounding trade names has spurred the government to set up a Central Drug Authority of India to handle manufacturing approvals with the authority to sanction a certain brand name.
Currently, a new drug manufacturing application has to be made to the Drug Controller General of India (DCGI) and both the central and the state governments are empowered to issue licences for drug manufacturing.
The central government lays down the legislative standards, clears new drugs, and supervises imports and exports; while the state government looks after manufacturing and the sale and quality of drugs.
With the establishment of the new central authority, all these functions would be centralized and the administration of manufacturing activity would be transferred in a phased manner to the Central Drug Authority.
The body is expected to be autonomous and function on the lines of the US Food and Drug Administration (FDA). The World Health Organization good manufacturing practice (GMP) norms would be followed by the body. It is also hoped that the body will interact closely with drug watchdogs abroad to harness regulatory expertise.
The executive wing of the regulator will be headed by the drugs controller. However, each division overseeing defined activities pertaining to drugs and cosmetics research and commercialization, would be largely independent. Empowering the Central Drugs Authority would require a few amendments to the Drugs & Cosmetics Act.
Relieving consumer confusion
Similar sounding brand names frequently confuse consumers who, owing to a lack of knowledge, take incorrect medication and end up with grave illnesses and complications.
For example, a patient consumed Unicontin, used to treat bronchal asthma, instead of Indicontin, which was prescribed for hypertension. Other similar names include Rinitrin, an anti-allergic medication and Ranitin, for gastric troubles; Wincid, an antacid and Wincip, a broad range antibiotic; Coxib, a non-steroidal anti-inflammatory drug and Coxid, used for tuberculosis. Adverse events that may occur as a result of dispensing the wrong medicine highlight the need to regulate pharma branding.
A pharmaceutical product typically has three names: the chemical name, which is the name of the molecule and which is mentioned in the patent application; a generic name, used to identify the formulation and is approved by WHO and DCGI in India; and the brand name, chosen by the manufacturer to distinctly identify and market the drug. This is the name consumers are most aware of.
Since the manufacturing of a product similar to already existing products is currently approved by the state licensing authorities, discrepancies arise when they are not aware of the branding exercise going on in other states.
This is sought to be rectified by the move to have a central drug licensing authority. According to an estimate, around 6,000-7,000 applications are rejected each year as they attempt to ride on the trade mark identity of an existing brand.
The authority is also designated to oversee the approval and continuance of the same brand name for formulations that have changed their composition, in an effort to combat brand ambiguity in the country.
Reforms on the horizon
The propagation of spurious drugs across the country is posing a serious threat to the regulatory setup as well as the health administration. Moves to control this have not yielded satisfactory results, mostly because the pharma industry stands astride between the chemical and health ministries.
The central government in the past five years has taken the necessary steps to introduce globally compliant laws for drug and cosmetics regulation, principally because India is emerging as a potential health market.
Multinational companies are permeating into the Indian market to sell drugs and conduct clinical trials, thereby giving impetus to Indian pharmaceutical research and manufacturing. With the global community looking towards us, we should make our vigilance mechanism stronger.
Abhai Pandey is a lawyer with Lex Orbis IP Practice, a law firm specializing in intellectual property issues.
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