Indian pharmaceutical firms are struggling to deliver standard medicine to its own population which came out by a recent alert from CDSCO which notified that many pharmaceutical formulations from renowned industries are failing simple dissolution tests.
Dissolution testing is a critical aspect of the development and quality control of pharmaceutical formulations. Dissolution testing ensures that the drug product is of good quality and that the active ingredient is released from the dosage form as intended. This is important because the therapeutic effect of a drug depends on the amount of active ingredient that is released and absorbed by the body. Dissolution testing provides a reliable and cost-effective method of assessing the bioavailability of a drug product.
In a recent alert, CDSCO notified that they had tested a total 1348 samples out of which 67 samples declared as not of standard quality. These samples were known to fail dissolution tests or simple assays and few are not contained mentioned weight per ml.
If a pharmaceutical formulation fails to pass the dissolution test, it means that the active ingredient in the drug product is not being released from the dosage form as intended. This could be due to several reasons, such as, poor formulation design, manufacturing process issues, poor quality raw materials or stability issues.
If a pharmaceutical formulation fails the dissolution test, it could have serious implications for patient safety and efficacy. The failure could lead to a decrease in the bioavailability of the active ingredient, which could result in a lack of therapeutic effect. In some cases, it could also lead to toxicity if the active ingredient is not properly absorbed and eliminated from the body.
It is interesting to know that these are random samples collected by the Drug Control Department of various states. Now, think about the number of samples which were not collected randomly and it would have failed otherwise.
Last month also CDSCO notified that around 70 samples failed out of 1375 samples. Every month around 4-6 % samples fail in this regard and it is a very serious concern because each batch contains tonnes of tables or capsules or other formulations. Now imagine how much harm it could done if they take such a failed formulation.
As per CDSCO, these types of defects are classified as CATEGORY A defect. As per DRUGS AND COSMETICS ACT, CDSCO take action on CATEGORY A DEFECTS, which includes,
1. To enquire in the matter immediately.
2. Issue instructions for immediate recall of the batch from the market and to stop further sale.
3. To ask for particulars of stock, distribution and production and test records.
4. Calling of explanation from the manufacturer by issuing a show cause notice as to why license for the product/entire licence should not be suspended/cancelled.
5. After receipt of explanation and/or investigation report, further appropriate action may be taken.
The weapon for prosecution should be used by CDSCO, sparingly and judiciously but due regard to merits of the case be given as a prudent measure. Prosecution should be launched where administrative measures have failed to have desired effects. However, while deciding to prosecute, due regard should be given to the nature of contraventions.
Indian pharmaceuticals firms have to take responsibility to produce quality medicines. Pharmaceutical companies in India are one of the largest producers of generic drugs globally. India's pharmaceutical industry is highly regulated by the government, and companies have to adhere to strict quality control measures and regulatory frameworks to ensure the production of safe and effective drugs.
In recent years, there have been some concerns raised about the quality of medicines produced by Indian pharmaceutical companies. However, it is essential to note that not all Indian pharmaceutical companies produce substandard drugs. Some Indian pharmaceutical companies have an excellent track record of producing quality medicines, and they are highly regarded globally.
Additionally, pharmaceutical companies must adhere to international standards like Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP) to ensure the quality and safety of their products. These standards help to ensure that the drugs produced meet the required quality standards, are safe for consumption, and are effective in treating the targeted diseases.
In conclusion, Indian pharmaceutical companies have a responsibility to produce quality medicines. However, it is important to note that the vast majority of Indian pharmaceutical companies produce safe and effective drugs, and the government has put in place regulatory frameworks to ensure that these standards are met.