Hind Latex to diversify into surgical sutures

Hindustan Latex, a government of India undertaking, is planning to diversify into the more lucrative Rs.250 crore surgical suture market. It also be part of the company’s move to spin-off a separate subsidiary dedicated to the health care business.

According to a senior company official, the surgical suture products range from single use absorbable (synthetic) and synthetic absorbable sutures for specialist and general surgeries.

Currently, the company is conducting awareness workshops for doctors in major south Indian towns and cities before unveiling the product in the market by September.

Hindustan Latex plans to corner at least 10% of the Indian surgical suture trade. 

To manufacture and sell surgical suture, the company has set up a dedicated facility at Thiruvananthapuram, having the capacity to produce 7m pieces per year. 

The drivers of growth for the health care division are expected to be manufacturing and selling blood bank equipment, blood bag exports, surgical stunts and emergency contraceptive pills.

The division recorded a turnover of Rs 7 crore in FY ‘02-‘03. This year, it has set a target of Rs. 15 crore with more sales coming from blood bag exports and surgical sutures. 

The company recently launched low-cost napkins priced at Rs. 20 for a pack of 10 as part of the company’s health care strategy.

Targeted at upgrading the lowest segment of the society, the company is mainly aiming at converting cloth users to napkins. “This initiative has covered the whole of south India and now the plans are afoot to tap select north Indian towns,” said the company official.

The company started operations in 1968 as a condom packing company.

It has now come to occupy a position in the country’s family planning, related health care programs and the health care product manufacturing business.

Currently, the company markets various commercial brands of contraceptives.

With manufacturing facilities in Thiruvananthapuram in Kerala and at Belgaum in Karnataka, the company has developed an array of oral contraceptives and other products such as blood bags and surgical gloves.

Over the next 2-3 years, the company will make investments to the tune of Rs. 50 crore. 

Last year, the company recorded a turnover which it expects to grow to Rs. 200 crore this year with significant contributions from exports and the health care division.

[Ref: Economic Times, 1/8/03]

Device PMA, 510(k) Review Fees Rise

Devicemakers will have to pay an average of 34.9 percent more to have their pre-market approval (PMA) applications and 510(k) submissions reviewed by the Center for Devices and Radiological Health next fiscal year. The fee schedule for fiscal 2004 includes a hefty $52,811 fee hike over 2003 for large device companies submitting full PMAs and a $20,068 fee increase for companies that meet the definition of a small business. For 510(k) submissions, the fees will rise to $3,480, a $1,293 increase over fiscal 2003. According to the agency the increase was necessary, in part, because of a $5.5 million fee shortfall in fiscal 2003. To see the new fee schedule, go to http://www.fda.gov/bbs/topics/ANSWERS/2003/ANS01244.html. NO WAIVERS FOR FOREIGN FIRMS, FDA SAYS The FDA said it will not accept foreign tax returns in lieu of federal income tax returns from companies seeking a small business user fee waiver. In a guidance document on qualifying for a small business waiver, the FDA said that, under the Medical Device User Fee and Modernization Act, a company that has not submitted a federal income tax return cannot qualify as a small business and must pay the standard fee for any medical device application. 

For the small business qualification guidance and worksheet, go to: http://www.fda.gov/cdrh/mdufma/guidance/1225.pdf.