In order to strengthen the drug regulatory mechanism in the North Eastern region of India, the Drug Controller General of India (DCGI) is planning to set up a Central Drug Standard Control Organization (CDSCO) sub zonal office at Guwahati by April, 2014. The plan would also involve strengthening of the drug testing infrastructure.
Licensing of blood banks, vaccines, medical devices and life saving medicines of 12 eastern zone states including seven states of North East is currently being done by CDSCO East Zone with its office at Kolkata. Eastern zone comprises of states - Bihar, Jharkhand, Orissa, West Bengal, Sikkim, Assam, Manipur, Mizoram, Nagaland, Arunachal Pradesh, Meghalaya and Tripura.
As per the plan, S K Mukhopadhaya will head the sub zonal office in the capacity of Deputy Drug Controller along with five drug control officers in a couple of months time. Says Dr G N Singh, DCGI, "This exercise is a part of the plan to curb the malpractices happening in the seven north eastern states due to lack of stringent enforcement of the law on account of lack of manpower and infrastructure. Moreover, the North East India shares its borders with Bhutan, China and Myanmar and hence is vulnerable from the aspect of getting smuggled not of standard and sub standard drugs and products, thus endangering patient safety”.
We are currently focusing on North Eastern part of India which has a weak drug regulatory mechanism and needs to be addressed urgently, he said.
Meanwhile, with the aim of ensuring safe supply of medicines, a team of drug control officials from the DCGI office is also in the process of doing surveillance through random sampling of medicines in consumer states of Odisha, Chhattisgarh and Bihar after completing a similar exercise in Jammu and Kashmir and Himachal Pradesh.
A glaring case in point is Arunachal Pradesh which is in need of manpower to enforce drug regulations. Besides facing a shortage of pharmacists with only 200 registrations done till date by Arunachal Pradesh Pharmacy Council (APPC), the state requires additional five drug inspectors to keep a tab on around 2000 existing drug retail stores for proper implementation of Drugs and Cosmetics Act.
Says Nangbia Tapin, registrar, APPC, "There are only six drug inspectors for the whole of Arunachal Pradesh and no drug testing laboratory in this sensitive border state. Establishment of drug testing laboratory is also required to check the standard and quality of drugs in Arunachal Pradesh."
Arunachal Pradesh with 17 districts has a unique topography and health services needs to be aligned to the demands of the populace. It is a thinly populated state located in the foothills of the Himalayas and divided into six natural regions. Characterized by mountainous ranges and sub-mountainous terrains, the state shares a long international border with Bhutan to the West, China to the North and North-East and Myanmar to the East.
Role of pharmacists in improvement of health sector in this distinctly located state can be further realized by setting up of drug information centre and appointment of pharmacists as Directorate of Health Services is not equipped to manage and handle the magnitude of work in the state healthcare sector.
"In order to address this problem in totality, a pharmacy college also needs to be set up to meet the shortage of trained pharmacists required in various health centres of the state under NRHM," Tapin said.
Arunachal Pradesh Chemist and Druggist Association (APCDA) along with Indian Pharmacists Revolution (IPR) Yatra Convener Amitav Choudhary have been pursuing their demands with the Chief Minister of Arunachal Pradesh Nabam Tuki related to shortage of manpower, setting up of drug testing lab, drug information centre and pharmacovigilance centre.
Pharmacists also have been raising demand setting up of CDSCO for North Eastern states
Udyog Development Foundation (UDF), a not for profit organisation which concluded the IPR Yatra from Kashmir to Kanyakumari on January 4, 2014 spearheaded the demand for setting up of a dedicated zonal office of Central Standard Control Organisation (CDSCO) for the North Eastern states of India on a priority basis.
IPR is also planning to submit a comprehensive proposal to the DCGI office, Planning Commission and the Union Health Ministry based on the survey done of the North Eastern States from July 15, 2013 to September 26, 2013 on the same. As per the proposal, there is an urgent need for upgrading regulatory mechanism in the North Eastern region because regulation and compliance for life saving drugs is very much neglected in this region of the country which shares its borders with neighbouring countries.
"North Eastern states share boundary with countries like Myanmar, Bhutan, Bangladesh and China and hence pose a grave risk of getting counterfeit, substandard and spurious drugs smuggled from across the borders into India," Choudhary explained.
The IPR has also demanded modernization of the Regional Drug Testing Laboratory (RDTL) for the North Eastern states. Besides this, RDTL at Guwahati is also facing shortage of manpower with mere 12 lab personnel. States like Sikkim, Assam, Manipur, Mizoram, Nagaland, Arunachal Pradesh has no drug testing laboratory with Tripura and Meghalaya having sick drug testing labs. There is also demand for establishment of drug information centre and pharmacovigilance centres in NE States.