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An in-house quality control laboratory (QCL) attached to a small herbal drug or Ayurveda drug manufacturing unit will enable the manufacturers to detect the genuine raw materials for the production of drugs and to achieve the desired quality of the product.
As per the Drugs and Cosmetics Act, certain minimum requirements are there for maintaining a small in-house QCL which is enough for doing some simple methods to detect adulterations. Quality control refers to the sum of all procedures undertaken to ensure the identity, purity and safety of a particular pharmaceutical product, according to Dr. Nagesh Sandu, managing director of Sandu Brothers Pvt Ltd, a leading Ayurveda pharmaceutical company in Mumbai in Maharashtra.
Dr. Sandu was delivering a speech on ‘QA and QC tests for Ayurveda and Herbal Drugs’ in a seminar in Vijayawada organised by the Confederation of Herbal and Ayurvedic Industries Associations (CHAI) of Andhra Pradesh on February 4.
Later, speaking to Pharmabiz, he said every manufacturer is supposed to follow the acts and the rules, but he has two options, either to set up an in-house lab or do the tests in a facility outside of the manufacturing unit. Even if the in-house lab is small, the manufacturer can go with some sort of simple QC tests like Thin-layer chromatography (TLC) to ensure the quality of his products. The D&C Act lays down certain minimum standards with a list of items to be set up in the small lab. Even with the help of a microscope, the herbal manufacturer can understand which is the genuine drug and which is adulterated. Simple chemical test is enough to reveal the colour reactions. The Schedule T of the GMP explains about the requirements and standards for an Ayurveda drug manufacturing company.
He said the manufacturer should employ a separate skilled person to be in-charge of the QC lab, who will check the production and ensure quality. He can easily detect adulteration and identify the genuine drug. If adulteration is there, it will not give the particular colour. The QC person should be an independent person and should not be from the manufacturing department which is focusing on the quantity, whereas the QC is focusing on the quality.
“The QCL person will check the manufacturing activities and if he finds any deviation, he will stop the production, rectify the deviation and restart the production. He is the authority. Secondly, there is the concept of IPQC or In-process quality control. During the manufacturing process, when the tablet machine is going on, after a period of time, there may be variation in the weight of a tablet. So, after every one hour you are supposed to ensure whether the weight of the tablet is within the acceptable limit. If it is not, the QC person will adjust it from a quality point of view. All these are supervised by the quality control person”, said Dr.Sandu.
When asked if a small company is financially not viable to set up one in-house lab, Dr Nagesh Sandu said the small players in an area can jointly put up one common laboratory for everybody’s use. Only through the QC department we can ensure the raw materials are authentic and in the prescribed quality. In the same way, the QC will help to understand that the manufacturing was done as per the prescribed standards. The IPQC will check whether any mistake or error happened in the manufacturing process, or any ingredient missed or added additionally. QC is the department that studies the shelf-life of the product. All these aspects are ensured by the QC person himself.
Further he told the herbal drug manufacturers of Andhra Pradesh that there is a need for generating different standards of herbal extracts as the extract used for medicinal purpose cannot be used for neutraceutical purpose. In the market, there are extracts for ayurvedic medicines and for neutraceuticals. But everybody does not know the fact that the standards are different for each one. He informed them that one company in Hyderabad has come forward with its intention to make different standards of extracts for Ayurveda industry and for neutraceutical industry.
He said, in some small companies the quality control and the quality assurance (QC and QA) are coming under a single person. But the QC has to be separated from the combined division as it has to be an independent department.
When asked whether he agrees with the concept of clinical trials for Ayurveda medicines, he said Ayurveda drugs are developed not from any new molecule like modern medicine, it is efficacy proven medicine in existence for thousands of years. But there should not be any compromise on the quality aspects.
Dr. JLN Shastri, former CEO of the National Medicinal Plant Board (NMPB) inaugurated the meeting which was chaired by Dr. Vemula Bhanuprakash Reddy, president of CHAI. Prof. SVV Ramashastri, senior Ayurveda doctor at the Government Ayurveda Medical College in Hyderabad spoke on Bio-diversity Act 2022.
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