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CIPI urges govt to create enabling environment for SSIs for playing key role in making drugs affordable
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Laxmi Yadav, Mumbai
September 29 , 2017
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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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