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Laxmi Yadav, Mumbai September 29 , 2017
In a bid to ensure availability of quality drugs and medical services at affordable prices, one of the main objectives of draft pharmaceutical policy, the Confederation of Indian Pharmaceutical Industry (CIPI) has appealed to the government to create an enabling environment for small scale units which are playing crucial role in making drugs affordable so that they can improve infrastructure to meet requirements of Schedule M of Drugs and Cosmetics Act.

India has around 3,000 SMEs out of the total of about 5000 pharma units. The small scale units have contributed significantly to keep prices of the drugs low in the country.  But, they are facing hurdles in producing quality medicines and maintaining norms of Schedule M.  The pharmaceutical manufacturers must comply with the minimum requirements of HVAC system and must be in working conditions. Only 40% of the SME units have achieved about 30% of the requirements. Another requirement is a perfect and validated water system, air & nitrogen free from impurities and moisture contents and in-house laundry. Only 40% units have achieved about 30% of the requirements, said PK Gupta, chairman of CIPI in a submission to Department of Pharmaceutical (DoP) which came out with draft pharma policy.

Talking about in-house testing laboratories, he said that there may be many companies who have installed IR, HPLC etc. but they may not be operative due to lack of knowledge. Many companies must not have installed specific instruments till date and depend upon the independent laboratories. Now a days small R&D center must be in every company for the development of pharmaceutical formulations, testing protocols and other allied services. Hardly any company may have R&D centres. All machines must be of GMP quality, if possible PLC control with automatic recording and printing. Plant & machine should be designed to give uniflow directions of man & material movement to avoid any cross contamination. May be only 10% units in SME sector have this facility, rest 90% needs to implement this. There is a huge shortage of trained technical staff in the industry. 20% industry may have maintained the documents related to performance qualification of the machine, process validation, MFR's, SOP's etc but are not authenticated and verified. A significant number of retailers and wholesalers hardly pay attention to proper storage of temperature sensitive drugs, he added.

Its high time infrastructure facility needs to be strengthened at state and central drug testing labs. Price control of 40 % drugs in the country are in force. There is a huge shortage of such drugs, CIPI chairman added.

For the production of API in India the scheme given by DoP is very much acceptable. It is very important that production of API must start in India and the price of such API should be competitive with China pharmaceutical industries. To achieve this API units must be given same facilities as given by China i.e. electricity on low price, centralized pollution plants, etc, it is also mentioned that mega parks will be established, he opined.

Gupta said that  for quality drugs we must have validated plants & machinery, HVAC, other utilities, R&D etc. All the norms published by the D&C Act must be implemented. He further stated that each and every industry must be visited by the state & central authorities in a friendly way while keeping in mind the existing situation of SSIs.

CIPI has proposed certain measures which if implemented will benefit SSIs. It says if any manufacturer is unable to comply with the requirements of the Act then it can be reduced to 1 to 2 working sections. A proper list of machineries, utilities etc. be prepared with the manufacturers. All the documents certified by the CDSCO should be given to the manufacturer so that there is no lack of  opinion.

If the manufacturer is short of funds or man power then they may be advised to get 3-4 units merged so as to get a single good unit. If the above proposal is not suitable then the unit can be converted in the field of R&D, testing labs, skill development centres and other-options to utilize his unit. From government side, training should be provided to the technical staff through workshops, seminars. Such training shall be given for minimum 5 years. Industry and the company can work together to provide such trainings. To maintain quality of temperature sensitive drugs, now a days freezers are available, which have capacity approx. 10 times to refrigerator. Such freezers can be installed in wholesaler/retailer shops, it suggested.

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