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GMP demands take pharma machinery makers to regulated markets
Prabodh Chandrasekhar, Mumbai | Thursday, March 25, 2004, 08:00 Hrs  [IST]

Gone are the days when Indian pharma machinery (IPM) manufacturers used to restrict their exports to the SAARC region. Today, with better GMP compliance, IPM manufacturers are getting enquiries even from lucrative markets like Australia, New Zealand, Spain, Norway, Sweden, Finland and new semi-regulated markets like South America, Malaysia, Thailand, Indonesia, and Vietnam, South Africa, and Morocco according to senior office bearers at the Indian Pharmaceutical Machinery Manufacturers Association or IPMMA.

According to IPMMA sources, out of the Rs. 500 crore-pharma machinery sales, more than Rs 200 crore worth sales come by way of exports. The sales are growing at an annual rate of 20 per cent.

Citing good demand from the South American market, the Indian Pharmaceutical Machinery Manufacturers Association or IPMMA has already appointed representatives there. Argentina, Brazil, Mexico and Chile are some of the major markets that the Indian pharma machinery manufacturers are targeting in SA.

"One-fifth cost advantage of Indian machines compared to European and US standards, a better adaptability of Indian machines to the pharmaceutical manufacturing requirements in these countries and above all strict GMP compliance followed by Indian machinery manufacturers are the factors for a growing demand from these markets. After all, however less expensive your product is, it will never find an international buyer until it meets international good manufacturing requirements," said Ratan Singhania, Gen. Secretary, IPMMA.

Besides, major 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.

Another reason for the Latin American pharma manufacturers to look for alternative machinery sellers from India compared to traditional US or the West European countries is the tight economic scenario in these countries. The currencies in countries like Brazil and Argentina faced severe devaluation with respect to dollar last year.

"Indian machinery manufacturers are perfectly evolving with changing times. Today, Indian machines are far better in quality and on 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.

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

15-20 per cent of the machinery used in the pharmaceutical industry in India is imported from abroad from countries like Germany and Korea. These are high-end machines used in tableting and capsuling.

"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.

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