The Kerala government will soon initiate steps for materializing the demand of the state pharma industry and allied sectors for establishing a comprehensive pharma park in the state, according to government sources.
According to sources, the government has now asked KINFRA, the nodal agency for implementing the project, to identify the area and it has found the suitable land in Kannur district.
Sources said that 40 acres of land was identified in Kannur district and it is an ideal place for the industrial cluster set up. However, the industry sources say that an area of 40 acres of land is not suitable for a comprehensive cluster for the pharma industry in the state. Kerala has more than 90 pharma manufacturing units and about 1000 marketing companies.
A few days ago, when the Union minister of chemicals and fertilizers visited the state, he had said that the central government would approve a pharma park in Kerala provided the state government identifies the land and provides infrastructure facilities. Moreover, the Kerala government has also plans and projects to develop the pharmaceutical industry and make the state self-sufficient in drugs production.
Meanwhile the decision of the government was welcomed by the Kerala Pharmaceutical Manufacturers Association (KPMA). M. Purushothaman Namputhiri, president of KPMA said that though most of the units in the association are small scale units, they will invest in the project. The park will contain sufficient infrastructure and other facilities for testing and analysis of drugs and also for imparting training to industry professionals.
Apart from the industry, several pharmaceutical organisations have made the demand for a pharma park in Kerala. The state pharmacy council had communicated to the Union and state governments for establishing a pharma park in Idukki district, and the government and private pharmacists associations had also demanded the government to set up the park in Wynadu district.
B Rajan, president of Kerala Pharmacy Council said 40 acres of land is insufficient for a comprehensive pharma park and Kannur is not an ideal place for it. He said the government should review its decision for the location and make it in Thiruvananthapuram district.
The ayurvedic medicine manufacturers and practitioners’ associations in Kerala are demanding to the Central and State governments that their concerns about the ‘Access and Benefit Sharing’ (ABS) Act should be eliminated before the ABS Act 2002 and the Rule 2004 are implemented fully in the state.
Even though certain states have implemented the ABS Act, there are some gray areas in the Act which need to be cleared immediately as they create confusion. Though the Act is supposed to be implemented in Kerala from June 1 this year, since the government has changed, it is unlikely to implement the Act soon, sources informed.
Pointing out certain gray areas that create confusion on benefit sharing, Dr P M Varier, national president of Ayurveda Drug Manufacturers’ Association (ADMA), said the association does not support the government to implement the Act as such because it will harmfully affect the small scale manufacturing units in the country. “More clarity has to come in certain provisions in the Act. ADMA has filed a case with the Nagpur court in Maharashtra against introduction of ABS and the association is waiting for the court verdict”, he said.
The Act demands fair and equitable sharing of benefits arising from the utilization of natural resources. For preparation of traditional medicines, the manufacturers use medicinal plants, herbs and other resources. The ABS Act mandates that out of the revenue they get from the sale of the products (drugs) they make, a certain percentage of it should be given to the government in lieu of exploiting the wild plants (natural resources).
According to Dr S Rajasekharan, former director grade scientist at the Jawaharlal Nehru Tropical Botanical Garden and Research Institute in Thiruvananthapuram, the amount levied from the users of natural resources will in turn be used for cultivating varieties of medicinal plants, herbs and for conserving wild plants with the support of local self governing bodies. Bio Diversity Management Committees will be formed under Corporation, Municipality and Punchayath levels and such committees will take care of the conservation of these herbs and plants. The local bodies are authorized to collect the levy from the users of these natural/genetic resources.
Dr Rajasekharan, who is the senior project consultant at the Kerala Bio Diversity Board, said access and benefit sharing is like collecting a royalty for the utilization of natural resources from those who commercialize the products they make out of these resources. If a manufacturer or a company engages in the production and sale of a product by utilizing the traditional knowledge, he is supposed to pay the royalty and licence fee to the biodiversity board as per the rules and regulations of the ABS Act and Rules. If an agreement (MoU) is signed in this regard it should contain specific indication about the percentage of ABS given for the harvest of natural resources.
“Everybody is utilizing the natural and wild resources, but nobody is taking initiative to replant the herbs or conserve the flora. The manufacturing companies are expending huge sum of money for advertisements for marketing their products and they make huge profit. Seventy percentage of their crude drugs are from the forest and even the rare species of vegetations are used for medicinal purpose. But they are unwilling to pay a little amount for conserving the natural resources. If the natural resources have to be protected, we need a sustainable harvest system and culture”, he said.
Dr Rejith Anand, general secretary of Ayurveda Medicine Association of India (AMAI) said government should implement the Act in such a way that it will not affect destructively the small scale manufacturers.
Source : Pharmabiz
Kerala would get the distinction to be the first state in the country to have pharmacy inspectors in all the districts of the state for strict enforcement of Pharmacy Act 1948. Currently, there are five pharmacy inspectors working in the state, while the government has accorded sanction to appoint nine more pharmacy inspectors.
The state government had last year accorded sanction to appoint seven more pharmacy inspectors on a proposal submitted by the Kerala State Pharmacy Council (KSPC), in addition to the five pharmacy inspectors currently working in the state to detect cases of violation of Pharmacy Act. Two posts were lying vacant for some time. All these nine inspectors are likely to be appointed by the end of the year as per the request by KSPC to the state health department.
After these appointments, Kerala would get the distinction to be the first state in the country to have pharmacy inspectors in all the districts for strict enforcement of Pharmacy Act 1948. KSPC is a statutory body functioning under the Kerala State Health Department. It is constituted under Section 19 of the Pharmacy Act, 1948 to regulate the profession and practice of pharmacy in the state.
According to the state council officials, the appointment of pharmacy inspectors will be helpful in carrying out timely inspections for effective check on illegal activities like dispensing of medicines by unqualified people. Informs B Rajan, president, KSPC, “Pharmacy Inspectors are appointed on a part-time basis from among the pharmacists of state government healthcare institutions who are supposed to carry out inspections in retail and government drug stores for the stipulated six day period in a month and then submit the inspection reports to the state council for further action.”
An honorarium is being paid to the pharmacy inspector from the funds generated through registrations by the state council. Until 2006, the council had seven inspectors with charges of two districts for one inspector but as of today two posts are lying vacant which are likely to be filled by September, 2014. Kerala has a total of 14 districts.
The council is a quasi-judicial body which can act against pharmacists by way of either issuing warning letters or canceling their registrations. Council can also take action against the offenders for violation of the Pharmacy Act under Section 36 wherein the executive committee of the state council can give the judgment based on the inspection report filed by the state Food and Drug Administration (FDA) official, oath of affidavit and explanation by the pharmacist.
The Consortium of Indian Pharmaceutical Manufacturers and Marketers Association (CIPMMA) has elected new office-bearers for the period 2014-2016 at their annual general body meeting held in Kodaikanal last week.
S Gopalakrishnan from Casid Pharma, Trichy is the new chairman of the organisation and M Ramaswami from Nano Syn Organics Private Ltd, Trichy is the president.
The AGM has elected 35-member executive committee and a seven-member apex body comprising the old office-bearers. The new office bearers will also attend the apex body meeting, said S Gopalakrishnan, chairman of CIPMMA.
Later while speaking to Pharmabiz, the chairman said his organisation would strive towards expanding the footprints of CIPMMA in the neighboring states of Kerala and Karnataka in the coming months. By the end of this year, the marketers association will have organisational units in all the revenue districts in Tamil Nadu.
The president Ramaswami said at present CIPMMA has presence in seven districts in Tamil Nadu and a membership strength of 300 marketers. It will be increased to 500 by next year. Two district units, in Dharmapuri and in Salem, will be inaugurated next month.
The AGM held in Kodaikanal was attended by manufacturers from Pondicherry. Several of the manufacturers in the union territory are members of CIPMMA. Next annual general body meeting will be held in Trichy in June 2015.
The former chairman Karunai Kadal and president A Kannan are among the apex body members.
Scientific evidence to prove the physical and chemical nature of the medicinal formulations is essential to develop and preserve the traditional medicines, especially Siddha drugs.
The evidences will provide proper scientific validation and significance to the fundamental principles of Siddha with special emphasise on the preparations like sindhooram, choornam, parpams (powder forms) etc, according to Dr. I G. Shibi, research officer at the department of chemistry, SN College at Chempazhanthi, Thiruvananthapuram.
Dr Shibi was presenting a paper on the subject ‘physico-chemical understanding of mineral based Siddha medicine’ at the Siddha physicians seminar at the Kerala capital organised by Central Council of Research in Siddha.
She said the material medica of Siddha system of medicine largely depends on drugs which are of metal and mineral origin and includes 11 types of metals, 25 varieties of salts, 64 numbers of mercurial, arsenical and sulphur compounds, and 120 kinds of minerals. So a scientific study of the Siddha formulations will be able to provide the scientific validations.
“The traditional system of sindhooram preparations involves grinding and calcinations of the materials several times. The various temperatures at which different stages of decompositions take place are never monitored scientifically in the traditional method. The chemical nature of the products formed at each stage of thermal decomposition is never understood in the traditional method. The effect of various gaseous atmospheres in the chemical changes occurring during the treatment and thermal decompositions of the materials is important,” she said while presenting the paper.
Further, the materials at different stages of preparations of a medicine are to be characterised by thermal, spectroscopic, diffraction, electron micrographic studies etc. Many features like surface area, porosity, pH point of zero charge, density, particle size etc are to be understood by proper methods.
According to her, the phyto-chemicals present in the plants used in the preparations of Siddha formulations are of interest to find new leads for treating different diseases. This chemical and therapeutic diversity of these compounds are widely viewed as a source of templates for structure optimisation programs designed to make new leads. Genuine attempts to link and apply modern branches of knowledge such as computer aided drug design, cheminformatics, artificial intelligence etc for rational drug development is imperative. Modern insilico methods are needed to ascertain the therapeutic effect and also to evaluate the druggability of these phytochemicals.