Paucity of drug inspectorate staff in J&K - major impediment in effective QC of Drugs

Over the past few years, an ever increasing concern is being
witnessed among the masses in regard to progressively deteriorating quality
of drugs and related services. Among a host of social, political, economic,
legal and administrative factors that are responsible for the prevailing
scenario, one big factor is the inadequacy of skilled manpower available
with the Drug and Food Control Organization, J&K in the shape of Drug
Inspectors.

As per official figures available with the health dept., there
are 7870 licensed retail and wholesale drug dealers registered in the state
of J&K with only 16 posts of Drug Inspectors to monitor and inspect them,
thus putting a burden of around 500 sale premises on each drug inspector
whereas internationally accepted norms require one drug inspector for every
100 drug sale outlets. It is worth mentioning that this figure of 7870
outlets does not include first aid centers, primary health centers,
allopathic dispensaries, sub-district and district hospitals that exist in
each district of the state in addition to blood banks, manufacturing
establishments and unauthorised drug stores. Thus the workforce currently
available with Drugs Control Department is not sufficient enough to fully
cater to the actual field requirements.

Guidelines put forth by well-known Hathi Committee (1975),
National Human Rights Commission (1999), Standing Committee on Petroleum and Chemicals (2001) have also prescribed one drug inspector for every 100
sale outlets or 25 manufacturing establishments. Accordingly there is need
for one drug inspector at every block level in the state whereas at present
only one drug inspector is managing each district and sometimes even two
districts of the state.

There are a total of 103 medical blocks in the
state. More than a year ago, a proposal framed by this author on behalf of
the J&K Pharmacy Graduates Association favouring creation of 90 fresh
posts of Drug Inspectors at Block level in the state was endorsed by the
Drugs Controller of J&K state and subsequently accepted by the Ministry of
Health and F.W., J&K for further consideration. However even after expiry
of more than a year, the said proposal is still lying pending with the
Ministry of Planning and Finance though all the concerned authorities had
assured prompt and favourable consideration of the same. The financial
implications of the proposal have been worked out at a meager amount of Rs.
1.10 crores per annum. This much financial burden on the state exchequer
should be quite bearable in the face of its potential benefits in terms of
an effective and fool-proof drug control mechanism in the state.

Moreover, at present, drugs falling under alternative systems of
medicine including Ayurveda, Unani, Siddha and Homeopathy are not regulated
by any legal framework so far as their sale, storage or distribution is
concerned. Though provisions relating to these type of drugs have been
outlined in the Drugs and Cosmetics Act, 1940 and Rules thereunder, these
provisions have not been enforced unlike other provisions relating to drugs
belonging to allopathic system of medicine. Therefore in case proposal for
the creation of 90 fresh posts of drug inspectors at block level is cleared
by the state govt., new appointees can be suitably empowered to inspect and
monitor drug stores dealing with alternative systems of medicine in their
respective blocks. Similarly diagnostic laboratories exist in every nook
and corner of the state without any license or proper registration because
of non- implementation of the Clinical Establishments Act in the state.
Proposed appointments of drug inspectors at block level can pave way for
the regular inspection, checking and statutory control of these
laboratories too provided relevant powers and authority is vested unto
them.

Govt. of India had envisaged under Para 13 & 19 of its National
Drug Policy, 1986, modified in 1994 the need to augment and strengthen drug
control and enforcement (inspectorate) staff in each state including J&K
with a view to enable statutory inspections to be undertaken as provided
under the Act. Funds were to be sanctioned under centrally sponsored
schemes for this augmentation. However, no remarkable augmentation has
taken place at least in the J&K state even till National Pharmaceutical
Policy 2002 was promulgated in February 2002 or thereafter. Ironically our
state of J&K does not have a Drug Policy of its own that could address our
regional requirements vis-a-vis making safe, effective and standard quality
drugs available to masses. In a previous article of mine, I had voiced some
concerns on this issue but of no avail till date.

Drug inspectors are the only personnel legally empowered to enforce
various provisions of the Drugs and Cosmetics Act. We should have them in
adequate numbers so that they share a manageable jurisdiction and workload.
Further, they need to be provided with adequate accommodation,
transportation, communication and judicial assistance facilities in order
to ensure prompt action. Govt. cites lack of finances as prime reasons for
inaction in these areas. However it is said that whenever adequate funds
are available with the state govt., these considerations always take a back
seat and remain last priorities with them. At present, the available
inspectorate staff spend most of their time in courts pleading for various
prosecutions launched by them and they are left with little time to conduct
any secret probe against possible spurious drug rackets operating in their
jurisdiction areas. There is urgent need to create separate intelligence
and legal cells in the state with adequate provisions of secret funds and
incentives for informers. It is therefore time to revive, revamp and
reconstruct our drug control administration on the pattern of other states
like FDA, Maharashtra so as to make drugs of best quality, safety and
efficacy available to consumers at reasonable rates. Govt. should stop
dilly-dallying the proposal of block-wise creation of 90 posts and the
proposal should be approved in the larger interests of the common masses.