The US Trade Representative (USTR) has questioned India for the country’s growing spurious medicine problem. According to the USTR report, nearly 20% of all pharmaceutical goods sold in the Indian market are counterfeit, which is a damning claim given India’s growing pharmaceutical market and its decades-long reputation as the “pharmacy of the world.”
The Indian pharmaceutical industry ranks third in the world in terms of volume, supplying 20% of the global demand for generic drugs. With a strong network of 3,000 drug companies and approximately 10,500 manufacturing units spread across the country, if timely efforts are not taken now, India may lag behind due to a lack of quality pharma products. In order for Indian pharma to rise in the global pharma order, certain aspects must be prioritized. These include holding marketing companies responsible for the quality of their products and enforcing strict quality controls, as well as encouraging innovation through increased R&D efforts.
The following factors can help to ensure that all Indian pharmaceutical products are of the highest quality:
As we prepare for a world without Covid, the focus should be on maintaining the highest standards of quality. The quality of Indian pharma products should be more in line with international standards, and suitable for public health. In order for this to happen, the health ministry has made regulatory changes to hold marketing companies responsible for drug product quality. Earlier, under the Drugs and Cosmetics Rules, the manufacturer of a drug was held liable for product quality and for taking action if there were any defects. Under these rules, the marketing company was immune from liability for drug quality. The ministry changed the rules to hold marketing companies accountable for their products’ quality. With the system now fully implemented, pharmaceutical companies will no longer be able to blame contract manufacturers for sub-standard products.
The newly amended rules will result in higher quality because both large and small marketing firms will be aware of their responsibility to own quality. They will procure products from quality-conscious contract manufacturers, and the overall quality will improve. This will also encourage low-quality manufacturers to raise their standards and work in a quality-conscious manner..
From the standpoint of competition the quality of all drugs, both at the time of approval and thereafter, must be ensured so that doctors and patients can be confident in their efficacy and safety.
According to reports, the government is considering enacting criminal penalties (including prison time) for companies that manufacture and/or market substandard drugs. Similarly, efforts are being made to track the movement of drugs from factories to pharmacies digitally. This step will help in ensuring that drug companies and distributors improve their quality control measures.Other concerns about quality regulation must be addressed, including the definition of quality, adequate drug-testing facilities, an adequate number of trained staff, post-market monitoring, and a mechanism for drug alert and recall.
Similarly, firm-level quality control requires significant improvement, including strengthening quality management systems, incorporating quality into product design, fostering a quality culture throughout the organization, and expanding and upskilling the quality and operations talent pool. It is up to the industry to put the recommendations into action. There can be no guessing when it comes to the quality of the healthcare ecosystem, particularly the pharmaceutical market. After all, the government, pharmaceutical companies, and healthcare professionals are all striving for quality.
Introducing Bar Code for all the drugs
In line with discussions it has been having over the last couple of years, the Drugs Technical Advisory Board (DTAB) has recommended that barcodes or QR codes be introduced in the top 300 brands of drug products available in the Indian market to help track and trace these brands. As members of the pharmaceutical industry, we believe that this should be the standard for all drugs produced in the country. What we must also keep in mind is that practically we will have to roll this out in various phases. Government will also have to help the manufacturers execute the same. This will help to reduce the threat of counterfeit the country. The QR code will aid in the tracking and tracing of medication throughout the supply chain, as well as ensuring its authenticity.
The barcode data must include the unique product identification code, the name of the API, the brand name (if any), the name and address of the manufacturer, the batch number, the batch size, the date of manufacturing, the date of expiry or retesting, the serial shipping container code, the manufacturing licence number or the import licence number, and any special storage conditions that are required (if any).
Niti Aayog, concerned about the spread of counterfeit drugs, proposed a plan to put the entire drug inventory produced and consumed in the country on a block chain, preventing fake drugs from entering the supply chain. To counter the problem of fake medicines, more such tech-aided solutions are required in the country.
Pharmaceutical Technology Upgradation Assistance Scheme (PTUAS)
Support for SME Industries is proposed under the PTUAS scheme, either through interest subventions of up to 5% per year (6 percent in the case of units owned and managed by SC/STs) or a 10% credit linked capital subsidy. The loan supported in both cases is limited to a maximum of 10 crores. For the five-year scheme, a budget of 300 crores has been set aside. PTUAS will assist small and medium-sized pharmaceutical companies in upgrading their plant and machinery systems, automating them, and maintaining quality. It will also help the country’s formulation of research and development.
Setting up a task force for quality checks
Despite the fact that there are quality checks mandated by the government in pharmaceutical companies, manufacturing plants, and even retail stores, there is still much to be done. The urgent need is to establish a task force whose sole purpose will be to ensure the quality of pharmaceutical products.The task force, which should be formed under the DCGI, should conduct several duties, including conducting raids on manufacturing sites, checking the stipulated production norms along with collecting samples from the sites.
API quality check
Currently, the quality of final medicine batches or pharmaceutical formulation is being tested. The government has set a few parameters for APIs to be used in formulations, but it has been observed that many companies are selling APIs that do not meet the requirements. Many small to large manufacturers use this inferior material to create their formulations and medicines. Beyond a point, it is difficult to calculate the pharmacopoeia specs of the API used in making it after the end dosage form/final formulation is prepared. The presence of these erroneous ingredients is frequently difficult to detect in the final product
The following is what we propose:
For critical APIs, the government mandates independent lab testing.
Random quality checks of API manufactured and sold by API manufacturers in accordance with pharmacopoeial standards established by the government for that API.
The production of APIs is regulated in most countries. These regulations necessitate a whole-systems approach to ensuring that an API is of highest quality. To allow the manufacturer to ensure the API consistently meets quality requirements, all components in this system must be properly designed, validated, maintained, and operated. In India, processes and controls must be effective and strictly enforced across the board, from cleanroom operations to instrument calibration and preventative maintenance in utility systems and these should be regularly checked by the authorities.
All of these measures can aid in the fight against counterfeit and sub-par quality medicines in India, allowing the country to truly become a world leader in pharmaceuticals.
Views expressed above are the author’s own.
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