Installation of quality air handling units (AHU) is essential for good manufacturing practices but even some of the major pharmaceutical companies in the country are not equipped with proper air management systems, according to experts who spoke at an event organised by the IDMA and PEG (Pharmaceutical Engineers Group) titled "Cost effective air management of non-sterile preparations" held in Mumbai last week.
According to Dr. M Venkateswarulu, deputy drugs controller of India, during the last 30 years, Indian GMP more or less has been matching the global current GMP norms. However, there are several areas in GMP, which Indian companies need to catch up globally and one among them is air handling, he said.
"Many of Indian companies manufacture in multi-product facilities, where there is a strong possibility for cross contamination. Air management therefore becomes critical in switching to sterile, non-sterile, ointment, liquids and hormones," said Dr. Venkateswarulu.
"The objective of companies should not be to satisfy FDA requirements but to be accountable to themselves and to the public they are serving. Even in quite a few well-established companies I have seen the service floors put up next to a junkyard or dust extraction system missing for their solid dosage facilities. For getting the right answers, a company has to constantly think on the basis of 'what has to be done' and 'why it has to be done'," he added.
Along with installing proper infrastructure ensuring quality, Indian companies also need to delve into factors that cause quality failure, he said.
Welcoming the alliance of IDMA and PEG, he opined that the two has to meet as many times a year as there is need for frequent dialogue between pharmacists and engineers for getting the knowledge up-to-date. A pharmacist can learn the right technical skills from an engineer and latter could make him more aware of current GMP requirements from the former, he said.
According to Technopak senior manager Sasidharan, GMP is 99 per cent common sense and one per cent engineering. According to him, sources responsible for causing air pollution in facilities include people (80%), airflow (5%), equipment (10%) and materials (5%).
BK Doshi of Doshi Consultants Pvt Ltd opined that Indian companies are more serious on GMP as compared to their Chinese counterparts. This could be traced from the fact that there are more number of WHO, US FDA and MHRA certified plants in India compared to those in China.
According to a senior drug control official who was present in the function, out of the 10,000 drug units in the country, only 400 are update with current GMP. Out of 2000 units among these, 35 per cent have complied with Schedule M requirements, another 15-20 per cent are expected to upgrade themselves by mid-2005, which is the latest extended deadline set by the government. About 200-300 companies are likely to survive by acting as contract manufacturers to larger firms.
"Almost 50 per cent of the total number of current units are likely to perish," he exclaimed.