India, world's biggest exporter of generics, does not have air quality filtration level norms unlike USA and Europe thus giving free hand to manufacturers to opt for air filtration of their choice at manufacturing plants.

This has serious implication on quality of pharmaceutical products. At times certain manufacturers taking advantage of it use not of standard air filtration at their plants thus compromising on quality of drugs.

Schedule M of Drug and Cosmetics Act which deals with various requirements for the manufacturing of drugs and pharmaceuticals including good manufacturing practice does not prescribe standards for air filtration to be used at manufacturing sites.

“High air purity is an essential requirement for production of pharmaceutical products. Presently the plants which adhere to US FDA and cGMP norms by default must follow stringent air quality filtration level norms – they do not have any other choice or shortcuts.  In the absence of local regulations, the SMEs are not bound to cater to specific filtration set ups which could lead to issues in product quality and environment health safety (EHS) issues,” said PKSV Sagar, managing director, Camfil India, a leading manufacturer of premium clean air solutions.

More often global players setting up plants in India usually adhere to US or European norms for air quality in the manufacturing process.

Any minor contamination during any of the complex processes – milling, grinding, sifting, mixing, coating, drying, filling, packaging can lead to complete batch failure.

Right quality and design of dust collectors are also an important aspect in the whole pharma manufacturing process. At times, the drugs being handled are hazardous and explosive in nature. Inferior equipment (dust collectors) can lead to unsafe conditions with operators and manufacturing equipment being exposed to major threats, he said.

Indian drug regulator, tightening norms to ensure safe and effective medicines for people in India, should come out with policy guidelines to ensure that pharma industry especially SMEs comply with air filtration quality.

“Not only pharma companies, suppliers to pharma companies (API plants) need to be covered with the similar regulations,” said Sagar.

Said Kapil Bhargava, chairman ISPE, India Affiliate and head of quality management & technical committee of Indian Drug manufacturers' Association (IDMA), “WHO GMP guidelines gives the recommended filtration levels for different levels of protection in a pharmaceutical facility. The government is taking steps to ensure that drug makers upgrade facilities to meet WHO GMP standards. To supply drugs to Jan Aushadhi stores, it has made it mandatory for drug makers to comply with WHO GMP standards.”


It is learnt that there are 10,000 drug units in India and of them, only 30 per cent are WHO GMP compliant. Another 20 per cent has taken steps to comply with it.

IDMA has more than 1,000 members. Of them, 70 per cent members are WHO GMP compliant.

American Society of Heating, Refrigeration, and Air-Conditioning Engineers (ASHRAE) 52.2 is dominant in USA and EN779:2012 is dominant in Europe. Both standards coexist in Asia and the Middle East.

Due to lack of Indian regulation determining air filtration level norms, drug makers in the country opt for US or European norms, said Sagar.