With the government bent on enforcing implementation of revised Schedule M1 of Drugs and Cosmetics (5th Amendment) Rules, 2006 on Homoeopathy sector, a large number of small and tiny units in are looking at the option of winding up their operations.

According to ISM industry observers, the revised Schedule M1 of the Drugs and Cosmetics (5th Amendment) Rules, 2006 for homeopathy units announced by the Union Ministry of Health will see over 90 per cent of the units shutting down across the country.

"There is a huge disparity between the large manufacturers and the tiny units. The homeopathy-manufacturing sector does not have a medium-sized industry segment which could match quality control standards of the big operators. The small industries operate in sheds and will find it virtually impossible to adhere to the Schedule M1 proposals like up gradation of facility and requirements of dedicated quality control divisions, well-equipped labs and qualified personnel. The investments would be unaffordable and going by the size of the operations, it would be wiser to wind up", pointed out VR Kannan, a pharma consultant.

Out of the 150 companies in the country, SBL Pvt Ltd, New Delhi, Dr Wilmar Schwabe Pvt. Ltd, the Germany based Homoeopathy giant, Baksons Drugs & Pharmaceuticals Pvt. Ltd, New Delhi and Bahola Healthcare, Chennai are the major players. The large part of the small companies is operating in West Bengal and northern states. A few companies are located in the southern and western regions. The market size is Rs 400 crore and growing at 25 per cent annually.

"The Schedule M1 norms insistence on specified plant infrastructure at a pollution-free location and to produce only Homoeopathy drugs, could result in faster exit of small units," stated Kannan.

A minimum of Rs 5 lakh to Rs 2 crore of investment is needed for the GMP compliance, stated Kartik Raghava Murty, managing director, Bahola Healthcare (P) Ltd.

As per the revised Schedule M1 of the GMP, the units should have areas for ancillary activities like warehousing, issue of raw materials, packaging materials, containers, closures and finished goods to facilitate easy maintenance. There should be area for equipment installation to ensure free flow of materials and check criss-cross movement of the personnel.

Other requirements included, area for container management with easily washable closures, secondary protective packaging of blister-packed products to protect the medicines from moisture and odour, manufacture of Mother Tinctures and Mother Solutions require 55 sq.m space with separate zones for Trituration, Tableting, Pills, Globules, Ointments and lotions.

Among the other requirements are, use of pure water free from pathogenic organisms approved under Homoeopathy Pharmacopoeia for drug manufacture, disposal of waste according to the Factories Act 1948 (Act 63 of 1948) and an equipped laboratory and quality control departments at all units. Maintain records of standard operating practices (SOPs).

Management has to provide uniforms, footwear, head-covers and gloves to workers, besides compulsory medical examination on a periodic basis and easy access to First Aid.

The norms demand technical staff appointment of only graduates in Homoeopathy Pharmacy or Science with Chemistry or Botany with minimum two years experience in testing and instrumentation.

"Homoeopathy is a popular system of medicine for scores of ailments including diabetes, cancer and cataract. Quality of drugs is critical for faster cure and drug compliance. The GMP guidelines will see small and poor quality manufacturers out of the market. There will be consolidation of the sector and improved standards of manufacture, leading to its increased recognition at home and abroad," sources in the directorate of AYUSH said.