Indian Pharma’s Future Success Depends on Rigorous Quality Control Measures

India has always been in the eye of the storm when it comes to the growing problem of fake medicines in the country. Even the United States Trade Representative (USTR) has scrutinized Indian pharmaceutical companies on this issue since, according to its report, about 20% of all drugs on sale in our market are counterfeit.

And it’s the kind of study that can harm India’s nascent market and reputation, even as it ranks third in the world by volume. India supplies more than 20% of the global demand for generic drugs, which is not surprising considering that we have more than 10,500 manufacturing units and 3,000 companies across our country.

But the fact remains that if the industry does not invest properly in the short term, India risks falling behind in the race for lack of quality products. To regain our place in the global pharmaceutical rankings, the industry will have to take certain measures such as encouraging innovation by increasing R&D expenditure, also holding marketing companies accountable for product quality and putting in place controls stricter quality.

Here are some other factors implemented that can directly result in improving the quality of Indian medicines and ensure that they are of the best quality in the future:

API Quality Check

At present, quality checks are only carried out for the final batches of drugs, but in the future, the government will also have to decide on the parameters of the APIs that will be added to the formulations. Indeed, some companies market APIs without checking their quality. Using inferior materials always results in poor quality drugs. Since it is difficult to understand the quality of APIs used in final formulations, we propose that for key APIs, there should be strict mandates for laboratory test parameters. Random quality checks of APIs manufactured and sold by API manufacturers should be standardized.

Introduction of barcode

The Drugs Technical Advisory Board (DTAB) has recommended the introduction of QR codes or barcodes for the top 300 drug brands available on the market. This is a great initiative and should become a standard for all drugs produced in India, but the implementation should be done in a phased manner. These codes facilitate the tracking of medicines throughout the pharmaceutical supply chain and guarantee their authenticity.

The barcode data must necessarily include the unique identification code of the product, the batch number, the batch size, the API and the brand name, the name and address of the manufacturer, the date of manufacturing and expiration date, shipping container serial number, manufacturing/import license number, etc.

Maintain quality control

In the post-Covid world, the emphasis is on best quality standards and Indian medicines must also align with these changing standards. Therefore, the Ministry of Health made regulatory changes to make marketing companies also responsible for quality. Previously, only pharmaceutical manufacturers were responsible for the quality of drugs. Under the amended conditions, no company will now be able to blame contract manufacturers for poor quality products, because whether they are large or small marketing companies, they will also be responsible for the quality of the drugs. Therefore, everyone will get quality products and the overall quality will be enhanced.

Establishment of the QC working group

Although strict quality controls are being mandated by the government in this industry, there are so many factors that leave a lot to be desired in this field. It is urgent to create a working group whose main objective will be to maintain the quality of the drugs produced. This team should be formed under the aegis of DCGI, and its tasks should include conducting raids on pharmaceutical manufacturing units, verifying stipulated production rules, and collecting samples from manufacturing units.

Pharmaceutical Technology Upgrading Assistance Program (PTUAS)

The government has offered to support SMEs under the PTUAS scheme, either through interest rate subsidies of up to 5% per annum (6% in the case of SC/ST owned and managed units) , or by a capital subsidy linked to the 10% loan. .

In either case, the loan is limited to a maximum of 10 crore. A budget of 300 crore has been set aside for the five-year program. The PTUAS device has been proposed to support SMEs and can also be used by pharmaceutical laboratories to modernize their manufacturing units and automate them; which will help maintain the quality standards of finished drugs.

These measures are just the start of a whole new quality journey for the industry. When used correctly, they will support the country in its fight against substandard and counterfeit medicines, pushing us to become the global pharmaceutical industry leader that we are meant to be.

About Sally E. Bartley

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