Himalaya has bagged a US patent for its product Picrolax for bowel management. The product which is now introduced in the domestic market is the first US patent certified herbal formulation from the company. US patent certification is given for the laxative property of the principle ingredient.

The clinical trials were conducted in leading institutes including Kolkatta Medical College, after which the report was published in the Medicine Update 2007 and Nizam Institute of Medical Science, Hyderabad, published in Gastroenterology Today 2007.

Picrolax is a single ingredient drug for acute sporadic constipation. The product is an US patented herbal formulation known with an onset of action within 4-6 hours and positioned for acute sporadic constipation, constipation associated with hemorrhoids, in pre and post operative conditions and in cardiac patients.

It is positioned as an ethically promoted drug which will be routed through physicians, general practitioners and surgeons. The company already has Herbolax for chronic constipation which is a multiple ingredient product with no patent, Philipe Haydon, president & CEO, Pharmaceuticals, Asia-Pacific, The Himalaya Drug Company.

The Indian laxative market is valued at Rs.215. crore and registering a growth rate of 8.57 percent according to ORG-IMS MAT September 2008, with an OTX base. The competition for Himalaya Drug Company will be from the lactulose, milk of magnesia, bulk producing, bisacodyl, irritant/stimulants, softners/emollients preparations.

The brand is launched all over India in October and expected to be launched in other countries, post registration.

According to Haydon, there has been an overwhelming response for the product. There is conviction about the rich in-house research background, US patent certification for the laxative property of the principle herb.

Causes of constipation are congenital, irritable bowel syndrome, systemic disorder (endocrine, metabolic or neurological), structural abnormality, slow transit constipation or pelvic floor dysfunction. Bowel management is a common problem in patients' anorectal obstruction or blockage.

The clinical trials conducted for the drug were open non-comparative human studies conducted on 200 patients(122 males and 78 females) at Kolkatta alone according to the ethical guidelines of the Declaration of Helsinki and was approved by the Institutional Ethics Committee. Patients were in the age group of 43 to 73 years. Patients with history of bowel movement difficulty gave informed and written consents. During the study all patients reported overall compliance and rapid symptomatic relief. There were no clinical adverse drug reactions and treatment discontinuation during the study period.