The new product patent regime and increased proportion of Indian pharmaceutical exports to advanced markets is gearing Indian pharma machinery manufacturers to better GMP and higher technological adaptation.

Indian machinery companies have started to follow proper documentation and maintenance of records for every manufacturing and maintenance procedure, which is demanded by international buyers, according to Rashmi Shah of Pharmalab.

"Currently all machinery manufacturers are upgrading their machines to meet new international requirements in terms of GMP, cGMP, CE, CFR 21 part 11 validation and all other directions," said Ratan Singhania, general secretary, IPMMA.

Indian pharmaceutical companies prefer domestically manufactured machinery over imported ones due to their easy adaptability, cost and user friendliness, latest design & technology, better after sales services. The Annual Maintenance Contract (AMC) on Indian machines is available at less expensive price compared to AMC on imported machinery, he said.

"Indian machinery manufacturers are perfectly evolving with changing times. Today, Indian machines are far better in quality and in par with international standards, than it used to be 15 years ago," said Dr. P.G. Shrotriya, Director, Technical, MJ Biopharm Pvt Ltd. Indian manufacturers follow the ISO 14000 and 9001 series of quality certification.

Pharmaceutical machinery manufacturing in India is predominantly a small-scale industry. According to IPMMA, there are 400 organised pharma machinery manufacturing companies and an equal number of unorganized units in the country. The unorganized manufacturers are usually component makers, who then supply to the organised manufacturers, makers of complete machine. About 150 manufacturers are already registered with IPMMA and are its members.

"Machines are tailor-made meeting requirements of the pharma industry. Every pharmaceutical company has its own system of procedures (SOP) for manufacturing and maintenance of its machines, as an effort to meet the latest GMP compliance. Keeping with this line, it would want the machinery manufacturer to follow a set of procedures with proper documentation in the manufacturing. Most of the time, it is the pharma manufacturer, which educates the machinery manufacturer on the latest fashion in the machinery and the upgradation in WHO GMP norms," said Dr Shrotriya.

As a reward to its better GMP compliance, Indian pharma machinery manufacturers are all set to enter the regulated markets in developed countries. Several IPM manufacturers have started getting enquiries from Australia, New Zealand, Spain, Norway, Sweden, Finland and some semi-regulated markets like Latin America, Malaysia, Thailand and Indonesia.