The need for better quality/compliance in Indian pharmaceuticalsNovember 2, 2022 2023-01-28 15:02
The need for better quality/compliance in Indian pharmaceuticals
The need for better quality/compliance in Indian pharmaceuticals
The Indian pharmaceutical industry is the world’s third-largest by volume and is expected to grow at a CAGR of 9.5% to reach $55 billion by 2020. The industry is highly regulated, and compliance management is essential to ensure that products are manufactured and distributed under Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP). Although, India is contributing majorly to the global medicine requirement, as per the USTR report, nearly 20% of all pharmaceutical goods sold in the Indian market are counterfeit. This is going to impact the growth of the Indian pharma sector eventually.
The regulations governing the Indian pharma sector
When it comes to the operations and governance of the pharma sector in India, it is subjected to the requirements of the Drugs and Cosmetics Act, 1940, and the Drugs and Cosmetics Rules, 1945. These regulations govern the manufacture, import, sale, and distribution of drugs and cosmetics in India. The objective of implying these regulations is to make the functioning of the pharma sector flawless and free from the trap of counterfeit drugs.
Besides, the pharma sector is also subjected to the requirements of the Medical Devices Regulations, 2017, which came into effect on 1 January 2018. These regulations govern the manufacture, import, sale, and distribution of medical devices in India.
The Indian pharmaceutical industry is highly competitive. With more than 3,000 drug companies and ~10,500 manufacturing units in India, following the right compliance measure is paramount. A robust compliance management system must ensure that it can meet the requirements of the various regulations.
Government’s initiative for better quality control
Quality control: Quality control is one of the most important steps in the medical manufacturing industry. It is important for companies to adhere to the highest quality medicine manufacturing compliances as per Indian and international regulations. The health ministry has made regulatory changes to hold marketing companies responsible for drug product quality.
Previously, as per the drug and cosmetic rules, the drug manufacturer was liable for product quality and action in case of any discrepancy. However, with the changed regulations, marketing companies are held accountable for product quality. The pharmaceutical company will no longer be able to blame contract manufacturers for substandard products.
With these amended rules, the marketing companies will hold themselves accountable and responsible for ensuring that the best quality medicines are dispersed in the market. They will procure your products from firms that follow stringent quality practices, eventually improving the medicine’s overall quality. Moreover, it will curb low-quality manufacturers and motivate other manufacturers to raise their standards and follow quality-conscious procedures.
Introducing Bar Code for all drugs– The next introduction by the government was a barcode for all drugs. The drug technical advisory board introduced the barcodes or the QR codes. This is applicable to the top 300 brand medicines in the Indian market. This will help in easy tracking and tracing of the brands.
Overall it is going to improve the trust in the brand. However, it is also important to note that this step must be introduced in different phases. Since the Indian market is wide, introducing such amendments in one go is challenging.
The barcode data will include a unique product identification code, name of the API, brand name batch number, bank size, manufacturing date of expiry, shipping details, manufacturing license number or the import license number, and special storage condition.
Overall it will have complete detail of the medicine from when it was procured to when it was delivered at the retail outlet.
Pharmaceutical Technology Upgradation Assistance Scheme (PTUAS) – This scheme was introduced to help small and medium pharma manufacturing companies. With this scheme, the government aims to provide assistance in the growth of pharmaceutical companies that have been adhering to high-quality protocols and have a good track record.
The government will provide interest subvention of up to 5% per year or a 10% credit-linked capital subsidy. The loan amount is limited to Rs.10 crore. The scheme has been introduced for five years and has a budget of Rs.300 crore.
Jindal Medical Store has been rendering outstanding services in the pharmaceutical sector for the past 53 years. While serving the global need, we believe that the Indian pharma sector needs stringent regulation policies.
While the initiatives mentioned above by the government are welcoming but we also recommend the following amendments to the operation and governance of pharmaceutical products and their quality in India:
Task force for quality checks-despite the stringent quality check procedure laid by the government, the issue of counterfeit drugs continues to haunt the pharmaceutical sector in India. Hence there is an urgent need to establish a task force whose sole objective will be to look after the quality of the pharmaceutical products.
The government was to introduce independent lab testing. This regulation makes a whole system approach mandatory to ensure that an API is of the highest quality. To adhere to this standard, it becomes mandatory for the system to be appropriately designed, validated, maintained, and operate it.
Wrapping it up !!!
With these changes being introduced in the market, we can expect the Indian pharmaceutical sector to grow multiple folds and establish a strong niche for itself on a global podium.
Jindal Medical Store (JMS)
JMS has been one of the topmost pharmaceutical exporters. They have an experience of more than 53 years. They deliver Super Kamagra at very affordable prices and of the best quality.
They have 72 distribution houses in 13 counties. It is one of the 19 exporters in this industry that has successfully served 79% of committed deliveries. They are certified with WHO-compiled products. They are the world’s 3rd largest supplier of Ajanta Pharma, Sunrise Remedies, and Centurion Laboratories products.
They offer a wide range of Erectile Dysfunction products, Prime Life Science Drugs, Anti-Cancer medicines, and Prime Ayurveda items. They have worked with customers from various countries like Russia, the USA, Canada, New Zealand, China, Saudi Arabia, Italy, and many others.