Indian Pharma’s Future Success Depends On Stringent Quality Control Measures
India has always been in the eye of the storm when it comes to the country’s mounting spurious medicine problem. Even the US Trade Representative (USTR) has scrutinised Indian pharma companies over this issue since according to their report approximately 20 per cent of all drugs on sale in our market are counterfeit.
And this is the kind of study that can adversely affect India's budding market and reputation, even as it ranks third in the world in terms of volume. India supplies over 20 per cent of the global demand for generic drugs, which is no surprise considering the fact that we have over 10,500 manufacturing units and 3,000 firms across our nation.
But the fact remains that if the industry does not invest correctly in the short term, India may fall behind in the race due to sheer lack of quality products. To regain our status in the world pharma rankings, the industry will have to take certain measures such as encouraging innovation through augmented spending on R&D, by making marketing companies also accountable for product quality and by implementing more stringent quality controls.
Following are some more factors implementing which can directly result in improving the quality of Indian drugs and ensuring they are of the best quality going forward:
API quality check
As of now, quality checks are only done for final medicine batches but, in the future, the government must decide on parameters for APIs that’re added to formulations as well. This is because some companies are marketing APIs without checking their quality. Using inferior quality materials always results in poor quality medicines. Since, it is tough to understand the quality of APIs used in the final formulations, we propose that for key APIs, there should be stringent mandates for lab testing parameters. Random quality checks of API manufactured and sold by API manufacturers should be normalised.
Introduction of Bar Code
The Drugs Technical Advisory Board (DTAB) has recommended QR codes or barcodes be introduced for the top 300 brands of drug products available in the market. This is a great initiative and must be made a standard for all drugs produced in India, but the implementation must be conducted in a phased manner. Such codes aid in tracking drugs throughout the pharma supply chain and ensure that they are authentic.
Barcode data must necessarily include unique product identification code, the batch number, the batch size, API & brand name, manufacturer name & address, date of manufacturing & expiry, serial shipping container code, manufacturing/import licence number, etc.
Maintain Quality Control
In the post Covid world, the focus is on best quality standards and Indian drugs must also align with these changing standards. Hence, the health ministry has made regulatory changes to make marketing companies responsible as well for quality. Earlier, only pharma manufacturers were liable for drug quality. Under the changed conditions, no companies will now be able to blame contract manufacturers for poor quality products as be it large or small marketing firms will also be liable for the drug quality. Hence, everyone will procure quality products and the overall quality will get boosted.
Setting up QC task force
Although strict quality checks are in the process of being mandated by the government in this industry, there are so many factors that leave much to be desired in this area. There is an urgent need for establishing a task force whose chief purpose will be to maintain the quality of manufactured drugs. This team should be formed under the aegis of DCGI, and their tasks should include conducting raids on pharma manufacturing units, checking on stipulated production rules, and collecting samples from the manufacturing units.
Pharmaceutical Technology Upgradation Assistance Scheme (PTUAS)
The government has proposed support for SMEs under the PTUAS scheme, either through interest subsidies of up to 5 per cent per year (6 per cent in the case of units owned and managed by SC/STs) or a 10 per cent credit linked capital subsidy.
In both cases, the loan is limited to a maximum of 10 crore. A budget of 300 crore has been set aside for the five-year scheme. The PTUAS scheme has been proposed to assist SMEs and can also be used by pharmaceutical companies in upgrading their manufacturing units and automating them; which will aid in maintaining finished drug quality standards.
These measures are just the beginning of an entirely new quality journey for the industry. When used properly, they will support the country in its fight against sub-par and counterfeit drugs, thus pushing us into becoming the global pharma leader we are meant to be.
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