The department of Ayush will be introducing good manufacturing practices (GMP) for herbo-mineral-metallic compounds known as Rasaushadhies, Rasamarunthukal, and Kushtajat products of Ayurveda, Siddha and Unani (ASU) medicines shortly.

The Ayush department's latest move for amending the Schedule T of the Drugs & Cosmetic Rules may put tremendous pressure on the manufacturers of these medicines by introducing this 'unnecessary regulation', industry sources feel. The supplementary guidelines deal with products like Bhasmas, Sindura, Pishti, Kajjali, Khalviya Ras, Kupipkwa, Rasayan, Parpati, Potali Rasa, Satwa (of metal and minerals origin), Druti Parpam, Karpu and Kushta etc used in Ayurveda, Siddha and Unani system of medicines.

The GMP is being introduced for this class of Ayush medicines to establish authenticity of raw drug, minerals and metals, in-process validation and quality control parameters to ensure that these formulations are processed and prepared in accordance with classical texts and for which safety measures are complied. Only those manufacturing units which have GMPs for ASU drugs and supplementary certificate for Rasaushadhies, Rasamarunthukal and Kushtajat formulations shall be allowed to manufacture the same.

As per the draft proposal, the manufacturers of Bhasma, Kupipkwa and Rasaushadhi preparations made from metals and minerals should provide specific areas which should be completely segregated from the production area used for preparation of plants and animal by-product based products to avoid contamination. There should be at least 100 sq feet areas separately for Bhatti or any other heating devise section; grinding, drying and processing section; and also for related store.

The manufacturing area should be designed with special attention to process the products that generate toxic fumes like SO2, arsenic and mercury vapour, etc. When heating and boiling of the materials is necessary, suitable ventilation and air exhaust flow mechanism should be provided to prevent accumulation of unintended fumes and vapours. Such areas may be provided with properly designed chimneys or ducts fitted with exhaust system and suitable scrubbing system to remove fumes and smoke, so that safety of personnel and environment is taken care of, the proposals said.