DCGI Calls Upon Indian Pharma Cos To Raise Standards Of Manufacturing Processes To Global Level

Chennai: As India has obviously become the manufacturing hub of pharmaceuticals for the medicinal requirements of the world population, it is necessary for the Indian companies to raise the standards of manufacturing processes to the global level, observes Drug Controller General of India (DCGI), Dr. Rajivsingh Raghuvanshi.

He said he is making this statement in the wake of concerns recently raised by regulators of foreign countries over the quality of Indian made pharmaceuticals. The drug regulator of India said the government received 18 international alerts in the last nine months, hence the government wanted to upgrade the good manufacturing practices (cGMP), the revision of which is in the offing.

Dr. Raghuvanshi was speaking as the chief guest in a function in Chennai organised by the Tamil Nadu drug manufacturers as part of the Regional Workshop of Revised cGMP for the pharmaceutical manufacturers in the state. He said the CDSCO has conducted 13 similar workshops in different parts of the country to sensitise the drug manufacturers about the New Schedule M provisions. This was the second program the DCGI was attending to explain the details about Schedule M after he attended the Baddi workshop.

Interacting with the industry people, the national drug regulator said the aspects of quality assurance (GMP) are the major issues the country finds as the bottleneck to meet global standards. He said although India is supplying pharmaceuticals to around 200 countries, there are a few companies who do not know how to make the products complying with international standards. After inspections at the production facilities, the regulators have found that some companies encounter the problem of either skill-deficit or will-deficit (lack of interest). In the case of NSQs, Dr. Raghuvanshi said, even certain companies do repeat the same batches of Not-of-Standard-Qualities. This shows that the companies do not know the proper process of pharmaceutical preparations as per the Indian Pharmacopoeia.

Another major issue raised by the regulator is that neither the public testing labs nor the private labs do keep the accurate data of the analysis when they are wanted for auditing or inspections. He said this is a major hiccup in collecting the test reports.

Dr. Raghuvanshi informed the Tamil Nadu drug manufacturers that the health of the people of around 200 countries is depending on Indian pharma and the fact that compels us to be more vigilant about quality aspects and conscious of responsibility. Further, he expressed the concern that huge gap is evident in the qualities of products marketed in domestic as well as in overseas markets. The exporter-cum-manufacturers should try to narrow down this gap to stabilize the quality of all the products being marketed either domestically or internationally.

According to him, the CDSCO has started the risk-based inspections at the production sites of manufacturing companies last year because the WHO and the US FDA were getting impatient about the quality of the Indian made drugs due to some unfortunate incidents happened in foreign countries. So far 269 companies were audited and 226 show-cause notices were issued in addition to 78 stop-production orders. The major anomaly found by the regulators during inspections is that some companies are not testing the raw materials they use in the production. Instead of pharmaceutical grade gelatin, certain manufacturers of softgel capsules use industrial gelatin imported from China. CDSCO has the data of such companies. He said actions will be initiated against such anomalies through the risk-based inspections which will continue to exist.

Dr S V Veeramani, chairman of the Pharmaceuticals Export Promotion Council (Pharmexcil) presided over the meeting which was attended by CDSCO deputy directors from Chennai and New Delhi, and the state DC of Tamil Nadu. J Jayaseelan, chairman of the TN IDMA welcomed the DCGI and other dignitaries, and Dr T Sathish thanked.

Meanwhile, responding to the issues highlighted by the national drug regulator, the chemical engineer of the popular softgel manufacturing company in Kerala, Sangrose Laboratories, Dr Thomas Alexander said there are very few manufacturers for softgel capsules in the country and they are all using Indian Pharmacopoeal grade (IP) gelatin. The former DC of Kerala, Revi S Menon, also commented that there is little chance for using industrial gelatin for manufacturing softgel capsules.

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