Arushi Jain, Director (Growth & Excellence), Akums Drugs & Pharmaceuticals Ltd
India has been noted for its longstanding and rising problem with fake drugs – according to a US Trade Representative report, approximately one-fifth of all pharmaceutical products sold in the country are counterfeit. Such a report is enough to tarnish India’s reputation as the ‘pharmacy of the world’ (it ranks third globally in terms of volumes by supplying over 20% of the global generic drugs’ demand) and upturn any future chances India’s emergent pharmaceutical market may have in the global market.
Our huge network of around 3,000 drug companies and about 10,500 manufacturing units may be able to offer more to the world, but will be denied the opportunity if timely efforts are not taken to uphold product quality. If the country continues to lag behind in quality issues, its extensive drugs pipeline will not find suitable takers. The only way forward for the industry is by prioritising quality matters and making excellence a non-negotiable condition. Starting with manufacturing companies to the ones marketing the drugs, each one has to make stringent quality the gold standard of assessing products. If we do not enforce strict quality controls at every turn, even our innovative drugs will not be welcomed by the world.
Here are some factors that can aid in ensuring that Indian drugs can match up to the highest quality standards around the world:-
- Overall upgrade of Quality Control (QC) procedures
The health ministry has in place regulatory requirements that make marketing companies responsible for drug quality; this is a 360 degree change from the previous regulations in which manufacturers were the responsible party. This means, pharmaceutical companies will no longer be able to shift any blame onto contract manufacturers for spurious products.
With marketing companies finally understanding the import of these amendments, they will also include their own quality checking mechanisms in the system. One way to do so would be by increasing reliance on quality-proud contract manufacturers. Other necessary factors include improved in-house quality control, incorporation of QC into product design, ample drug-testing facilities and sufficient trained testing personnel, digital tracking of drugs, seamless drug recall procedure, etc. To offer a helping hand, the administration is considering criminal charges and penalties for companies indulging in fake drugs as well.
If this trend continues, all sorts of manufacturers will be pushed to raise their quality standards and India’s medicines will be known for their quality as well as innovation.
- Appointing necessary QC taskforce
Despite mandatory QC measures in place, a need is felt to appoint a taskforce that solely aims to ensure the quality of drugs. Such a taskforce can be housed under the DCGI and could be responsible for conducting raids, checking stipulated production norms, sample collection, etc.
- Introduce Bar Code for every drug
The Drugs Technical Advisory Board has suggested mandatory barcodes or QR codes be introduced for the key 300 brands of drug products available in the Indian market. This will make tracking drug brands gainful and thus QC easy. But as per experts, this should become the standard practice for all drugs manufactured within the country. While the roll out of such an extensive programme could be designed in a phased manner, its necessity cannot be denied.
Concerned by the growing instances of counterfeit drugs, Niti Aayog had proposed that the entire Indian drug inventory be appended by block chain. This may be another great suggestion to use AI in countering the fake medicines issue.
- Conduct API QCs as well
At present, pharma-related QCs are only conducted at the time of the final formulation. But there’s a major challenge in the form of the quality of APIs that needs to be addressed. While per law APIs can be used in formulations, many companies are selling APIs that don’t meet industry quality standards. Usage of such inferior raw material in drugs will no doubt lead to manufacture of sub-standard drug formulations. To deal with this issue, a two-tiered approach is necessary.
Firstly, the government needs to make independent laboratory testing mandatory for critical APIs. Also, random checks on all manners of APIs need to become an accepted industry practice. By enforcing these procedural upgrades, we can regulate the API QC issues.
In India, the issue is not as much about regulations and mandates as it’s with the actual enforcement of them. Enforcing the measures appropriately is a must in the war against substandard drugs, if the country wants to continue to be recognised as world leaders in the pharmaceutical industry.
