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A person of Dr.Subramanian Swamy’s nature, is always prone to attack the targeted politician or topple the targeted ruling government - irrespective of the party- Congress, BJP, DMK ADMK etc.,.Once he decides to take on the politicians- he is not bothered about the targeted person’s stature, power, clout etc., and also doesn’t settle for compromises with them on withdrawing his case later at any circumstances. When Jayalalithaa offered for an alliance with Dr.Swamy’s Janata Party in 1997, he accepted only after making it clear to her that he will not withdraw the disproportionate case against her! Obviously he has more enemies than friends in the political circles given his questioning and criticism of rivals.Dr.Subramanian Swamy is not like politicians in general who allege/criticise their opponents without any authentic evidence. Dr.Swamy is clinical in his approach- before alleging his opponents, goes deep into the issue, analyzes the factual details, gets support from whistle-blowers in Government departments / private sectors to get reliable information, actual document copies, synchronizes the facts and presents an elaborate and authentic evidence - gives his heart out for the execution and presents the case mostly by himself to ensure that the judiciary finds no fault in admitting the case. From there he starts to nail the coffin!Interestingly he is not a lawyer by traditional educational practice. Dr. Swamy did his Bachelor’s degree in Mathematics in Hindu College from the University of Delhi, MA in Statistics from the Indian Statistical Institute, Calcutta and Ph.D in Economics from Harward University- It has to be noted that under Nobel Laureate Simon Kuznets he obtained doctorate in Economics in 1965.His wife Roxna (a Parsi) is a lawyer by profession and assists him in legal cases.TURNING POINT IN DR.SWAMY’S POLITICAL CAREER:The first time he ever argued in court was in 1982. This was when Ram Jethmalani (he was then with the BJP and Dr.Swamy was with the Janata Party) filed a criminal defamation case against him. It was a turning point in his life.Most lawyers told him that they did not want to appear against Jethmalani. Dr.Swamy’s wife, who is a lawyer, had a highly rated criminal lawyer friend PR Vakil who advised him to argue himself. He coached him to argue. So, that is how it began. He argued that case, and won it too, with Jethmalani on the opposite side!He has single-handedly filed cases against high profile leaders like Jayalalitha, P.Chidambaram, Sonia Gandhi, Rahul Gandhi, Priyanka Vadra etc.,Historically there are instances where Dr. Swamy has also toppled the ruling government. He has also successfully defended a few cases against the ruling Government-Impact of Dr.Swamy in Indian Politics:During Emergency : During India’s emergency days under the rule of Indira Gandhi, when almost every leader, whom the state (read Indira Gandhi) considered a threat for its existence, was put forcibly in jail or house arrest, here was a professor at Harvard who took to the system head on and in a typical Bollywood style. When arrest orders were out in his name, and all national airports were intimated to arrest Swamy on sight, the man not only reached the country of his birth (taking it on as a challenge), but also stepped inside the Parliament (in disguised form) and challenged the incumbent rule raining voice against him (and others like him). Interestingly, he even left the nation without getting trapped by security forces. This tells a lot about the courage this man had.Made it Possible for Indians to Access the Kailash MansarovarSubramanian Swamy played an important role in making it possible for people of Hindu faith in India to access the Kailash Mansarovarreligious pilgrimage route.Mount Kailash MansarovarTo make it happen, he had met Deng Xiaoping China’s top guy of the time (April 1981).Dis-appropriation of assets case against ex-Tamil Nadu CM Jayalalitha: Case flied in 1996 and convicted on 27 Sep, 2014.Image source: http://India.comPhone Tapping case against ex -Karnataka CM Ramakrishna Hegde in 1988. Dr.Swamy released a letter alleging that a former intelligence chief had asked the Department of Telecommunications (DOT) to tap the phones of many businessmen and politicians. In the resulting controversy, Karnataka Chief Minister Ramakrishna Hegde had to resign.2-G spectrum Case against Ex Telecom Minister A.Raja- Both Raja and Kanimozhi were arrested in 2011 and sent to Tihar jail.Aircel- Maxis Case- Kalanidhi Maran and Dhayanidhi Maran were accused in the back drop of the 2G Case. In 2012, Swamy alleged that P Chidambaram delayed permission for the sale of Aircel to the Malaysia-based Maxis to ensure that his son Karti Chidambaram could benefit financially.Image source: TimesnowNational Herald Case against Sonia Gandhi and Rahul Gandhi.As per the complaint filed in the court of the Metropolitan Magistrate, Associated Journals Limited (AJL) took an interest-free loan of ₹90.25 crore (US$13 million) from Indian National Congress. It is alleged that the loan was not repaid. A closely held company, Young Indian, was incorporated in November 2010 with a capital of ₹50 lakh (US$70,000) and it acquired almost all the shareholding of AJL and all its properties (alleged to be worth ₹5,000 crore (US$700 million)). Swamy alleged criminal misappropriation by both Sonia Gandhi and Rahul Gandhi. The courts have determined that a prima face case has been established in the matter.Source: tv9Company law violation of Priyanka Vadra and Karti Chidambaram: In May 2014, Swamy filed complaints against Priyanka Vadra and Karti Chidambaram with the corporate ministry alleging that the two had multiple Directot Identification Numbers (DINs), which is not permissible under the Companies Law. Priyanka admitted to mistakes in submitting multiple applications for DINs while Karti Chidambaram was asked by the corporate affairs ministry to explain his position on a related issue.Sonia Gandhi-Black Money accusation: In 2014, Swamy alleged that Congress president Sonia Gandhi had stashed away black money in three secret accounts in different foreign banks. Swamy, a known Sonia-baiter, said she had secret accounts at Vatican Bank, Sarasin Bank in Basel and Pictet Bank in Zurich.Sonia Gandhi Nationality: Dr.Swamy was among the first to question Sonia’s Italian roots and her decision to join politics after her husband Rajiv Gandhi’s death and continues to take potshots at her.2015: Irregularities in Spicejet sale: During April, 2015, Dr.Swamy wrote a letter to Prime Minister Narendra Modi seeking a probe into the SpiceJet buyout. Dr.Swamy raised question on Ajay Singh’s source of funds and the capital market regulator’s move to exempt the new promoter from making an open offer despite acquiring 58 per cent in the airline.1991: Dismissal of DMK Government:TN CM Karunanidhi’s Government was brought down by Dr.Swamy (he was then the law minister in PM Chandrasekar’s cabinet) for actively supporting LTTE.since then there has been animosity between the two. In 1997, Swamy made a list of charges against Karunanidhi anddragged him to the court.Sethu Samudhram Project: Karunanidhi’s pet Sethusamudram Shipping Canal Project, which was planned to link India and Sri Lanka, was also met with stiff resistance from Dr.Swamy who argued against it on court on religious grounds, saying that it would damage mythical Ram Sethu.2013: Freeing the famous Chidambaram Natraj Temple from the State Control:The Supreme Court delivered a landmark judgement on January 6, 2013, allowing Dr.Swamy’s Special Leave Petition that sought the quashing of the Tamil Nadu Government’s G.O. of 2006 which had mandated the government takeover of the hallowed Sri Sabhanayagar Temple (popularly known as the Nataraja Temple). After the verdict Dr.Swamy said: “What is scandalous is the corruption after the takeover of temples as politicians and officials loot the temple’s wealth and land, and divert donations of devotees to non-religious purposes”Chidambaram Natraj Temple1999: Ousting Vajpayee ‘s BJP Govt: He brought down Vajpayee’s BJP Government by bringing together Sonia, Jayalalitha & Mayawati in a Tea-Party! Dr. Subramanian Swamy dislikes Vajpayee for tricking the late prime minister Morarji Desai, during Janata Party rule into keeping him out of the senior cabinet by bestowing him with the rank of minister of state. Swami has several times casted aspersions about the private life of Vajpayee through his blogs or interviews.Jaya, Sonia and Dr.Swamy at The tea party!Removal of RBI Governor Raghuram Rajan:Dr.Swamy wrote to Prime Minister Narendra Modi recommending that he "consider terminating the appointment" of Reserve Bank Governor Raghuram Rajan "effective immediately or when his term ends" in September,2016. In his letter to the PM, Dr.Swamy accused Dr Rajan of an "apparently deliberate attempt to wreck the Indian economy," and contends that the RBI governor is "mentally not fully Indian." since he continues to renew the Green Card issued to him by the US government. Finally as there was no consensus to his extension, Raghuram Rajan had to demit office.Defamation Cases against Dr.Swamy:Dr.Swamy won every defamation case filed against him. Tamil Nadu Chief Minister Jayalalitha filed close to 100 defamation cases against him in different courts between 1992 and 1996. He took the matter to the Supreme Court and got the famous New York Times Case of 1964 read into law. It provided that if a person in public life, including one in government, feels aggrieved by a defamatory statement, then that person must not only prove in the court that the defamatory statement is false but also that the maker of the statement knew it to be false. This principle, thus, reversed the traditional onus on the defamer and placed the burden of proof on the defamed. Later, Jayalalitha withdrew all the 100 cases filed against him.Subsequently, Jethmalani filed three more defamation cases and lost all of them. He found that people realised that He’s an authority in defamation cases that they stopped filing defamation cases against him. No such case has been filed against him since 1998.Dr.Swamy - The One Man Army!: The above facts establish the strengths of Dr.Swamy- If he files a case against a politician, it will be lethal and at the same time he is almost impossible to be attacked in the court of law- as he is a master in defending himself against any defamation case.Dr.Swamy has his own likes and dislikes on the policies of various parties and politicians and he never hesitates to attack the party or politician - even if he is close to some of them. In his political career, he has never had a permanent friend or foe in politics, which makes him unpredictable always - and that’s the reason most of the politicians are always careful in maintaining a distance with him! Some politicians have also utilised his services to dislodge their political rivals!It’s not a surprise that BJP has allowed to merge Dr.Swamy’s Janatha Party with the BJP- just to utilise his strengths!Understanding the nature of Dr.Swamy, Modi has retained him within his party and has let his focus on corruption / defamation charges against opposition leaders- especially the Congress!Criticism on Goverment Policies & BJP Leaders:All said and done keeping Dr.Swamy quiet without criticism on BJP is also difficult. He has been critical on some of the top BJP leaders like the Finance Minister Arun Jaitley, consistently and also voiced his opinion against certain decisions like GST and demonetisation- he openly commented that it’s a disaster and the Finance ministry is to be blamed for it!By keeping Dr.Swamy within the party itself is on many occasions an embarrassment to the party and the Government, but keeping him out of the party will only be disastrous to them!Now coming to the question,Modi doesn't really fear Dr.Swamy. If fear of Dr.Swamy is the core factor, he would would have given him a ministerial portfolio. But Modi has not given him any! Instead Modi has only utlized Dr.Swamy's core strength-ie., to focus and expose the opposition and at the same time keep his criticism of the party and the government within control! Dr.Swamy too has compromised a bit with the party for not demanding any ministerial portfolio due to his closeness with Modi - And Modi too hasn’t tried to control Dr.Swamy whenever he has criticised some of the Ministers or the party in general- so far it’s a win-win situation for both!But wait, Dr.Swamy is very unpredictable and could turn against Modi and BJP as well anytime!!!Images: Google

Everything in Singapore is monitored, cars especially, as they are not only taxed here, they are taxed many times over, from ARF to ERP to road tax to COE (which is a kind of tax).There is an expiry date on COE, and when the date is reached, the owner chooses either to renew the COE for 5 or 10 years, which he can do with the help of a COE renewal loan, (because COE are not cheap, currently at about the $33k mark) or he has to scrap the vehicle at an authorised scrap yard which then informs LTA (Land Transport Authority) that the car is now scrapped.If the COE is not renewed, the government loses revenue and so they do keep a sharp eye out on such things.Within one month after expiry date, the owner is expected to renew it or send it to scrap yard.The moment COE expires, it becomes an offence to drive on the road. There can be a heavy fine for getting caught. And it’s easy to get caught because of ERP and other electronic monitors (like traffic cams everywhere) which catch the signal from a moving car from its IU (a device that electronically deducts cash from you as you pass certain places). If they catch a car passing that has COE expired, well, you expect to get a terse letter from the authorities.So the only thing to do is to leave it parked first if expired and get it renewed as soon as possible. Or get it towed to the scrap yard.

LOAN LICENCING is a pure business arrangement and all normal business regulations will apply.You will have to enter into a loan/ licence manufacturing agreement with the facility/ factory owner________________LOAN LICENCING in Pharmaceutical Manufacturing is the term used for getting manufactured own product at other’s premises at LOAN LICENCE contract.LOAN LICENCING is just like hiring/ renting others manufacturing premises for manufacturing owns products.LOAN LICENCING require two parties: One is marketing company and second one is manufacturing company.In LOAN LICENCING marketing company can use its company name at place of manufactured by address but address will of manufacturer’s company premises.It is similar to third party manufacturing but has few differences.In LOAN LICENCING you can use marketed by address and manufactured by name of your company.LOAN LICENCE: Under Drugs and Cosmetics Rules, A Loan license is defined as “For the purpose of this rule a LOAN LICENCE means a license which a licensing authority may issue to an applicant who does not have his own arrangements for manufacture but who intends to avail himself of the manufacturing facilities owned by a licensee in FORM 25 or in FORM 28 as the case may be.”____________________________LABELLING REQUIREMENTS ARE AS FOR PROBIOTICSSchedule – X (See regulation 10) List of Strains as Probiotics (Live Micro- organisms) 1 Lactobacillus acidophilus 2 Lactobacillus planatrum 3 Lactobacillus reuteri 4 Lactobacillus rhamnosus 5 Lactobacillus salivarius 6 Lactobacillus casei 7 Lactobasillus brevis 8 Lactobacillus infantis 9 Lactobacillus johnsonii 10 Lactobacillus bulgaricans 11 Lactobacillus asporogenes 12 Lactobacillus fermentis 13 Lactobacillus caucasicus 14 Lactobacillus helvetucs 15 Lactobacillus lactis 16 Lactobacillus amylovorus 17 Lactobacillus gallanarum 18 Lactobacillus debrueckii 19 Bifidobacterium bifidum 20 Bifidobacterium lactis 21 Bifidobacterium breve 22 Bifidobacterium longum 23 Bifidbacterium animalis 24 Bifidbacterium infontis 25 Streptococcus thermophilus 26 Streptococcus bouraldi 27 Saccharomyces species (as in codex) PS: These organisms may be used either singly or in combination but must be declared on the label with full information and has to be non-GMO.Schedule – XI (See regulation 11) List of Prebiotic Compounds 1 Polydextrose 2 Soybean Oligosaccharides 3 Isomalto-oligosaccharides 4 Fructo-oligosaccharides 5 Gluco-oligosaccharides 6 Xylo-oligosaccharides 7 Inulin 8 Isomaltulose 9 Gentio-ologsaccharides 10 Lactulose 11 Lactoferrin 12 Sugar alcohols such as lactitol, sorbitol, maltitol, etc.____________________________For revised FEES/ FORMS update kindly refer to Website of Drug Controller etc.loan licence1[70A. Form of loan licence to manufacture for sale 2[or for distribution] of drugs other than those 3[specified in Schedules C, C (1) and X].—A loan licence to manufacture for sale 2[or for distribution] of drugs other than those specified in 2[Schedules C, C(1) and X] shall be issued in Form 25A.]73A. A certificate of renewal of loan licence—The certificate of renewal of a loan licence in Form 25A shall be issued in Form 26A.]73AA. Duration of loan licence—An original loan licence in Form 25A or renewed loan licence in Form 26A, unless sooner suspended or cancelled, shall be 1[valid for a period of five years on and from the date on which] it is granted or renewed:2[Provided that if the application for the renewal of a licence is made before its expiry or if the application is made within six months of its expiry, after payment of the additional fees, the licence shall continue to be in force until orders are passed on the application and the licence shall be deemed to have expired if the application for its renewal is not made within six months of its expiry.]1[75A. Loan licences.—(1) Applications for the grant or renewal of loan licences for the manufacture for sale 2[or for distribution] of drugs specified in Schedules C and C(1) 3[excluding those specified in Part XB and Schedule X] shall be made in Form 27A to the licensing authority and 4[shall be made upto ten items for each category of drugs categorised in Schedule M and Schedule MIII and shall be accompanied by a licence fee of rupees six thousand and an inspection fee of rupees one thousand and five hundred for every inspection or for the purpose of renewal of licences]:5[Provided that if the applicant applies for the renewal of a licence after its expiry but within six months of such expiry the fee payable for renewal of the licence shall be rupees 4[rupees six thousand and an inspection fee of rupees one thousand and five hundred plus an additional fee at the rate of rupees one thousand] per month or a part thereof.]Explanation.—For the purpose of this rule a loan licence means a licence which a licensing authority may issue to an applicant who does not have his own arrangements for manufacture but who intends to avail himself of the manufacturing facilities owned by another licensee in Form 28.(2) The licensing authority, shall, before the grant of a loan licence, satisfy himself that the manufacturing unit has adequate equipment, staff, capacity for manufacture and facilities for testing, to undertake the manufacture on behalf of the applicant for a loan licence.6[(3) Subject to the provisions of sub rule (2), the application for manufacture of more than ten items of each category of drugs on a loan licence, shall be accompanied by an additional fee at the rate of rupees three hundred for each additional item of drugs.(4) If the licensing authority is satisfied that a loan licence is defaced, damaged or lost, he may, on payment of a fee of rupees one thousand, issue a duplicate copy of loan licence.]76A. Form of loan licence to manufacture for sale 2[or for distribution of] drugs specified in Schedules C and C(1) 3[excluding the drugs specified in Schedule X] and conditions for the grant or renewal of such licence.—A loan licence to manufacture for sale 4[or for distribution of] drugs specified in Schedules C and C (1) 5[excluding the drugs specified in Schedule X] shall be issued in Form 28A, and the applicant shall, while applying for a licence to manufacture patent or proprietary medicines, furnish to the Licensing Authority evidence and data justifying that the patent or proprietary medicines—(i) contain the constituent ingredients in therapeutic/prophylactic quantities as determined in relation to the claims or conditions for which the medicines are recommended for use or claimed to be useful;(ii) are safe for use in the context of the vehicles, excipients, additives and pharmaceutical aids used in the formulations and under the conditions in which the formulations for administration and use are recommended;(iii) are stable under the conditions of storage recommended; and(iv) contain such ingredients and in such quantities for which there is therapeutic justification.]1[83A. Certificate of renewal of a loan licence.—The certificate of renewal of a loan licence in Form 28A shall be issued in Form 26A.]295 [ 83AA Duration of loan licence. —An original loan license in Form 28A or renewed loan licence in Form 26A, unless sooner suspended or cancelled, shall be 296 [valid for a period of five years on and from the date on which] it is granted or renewed:297 [Provided that if the application for the renewal of licence is made before its expiry, or if the application is made within six months of its expiry, after payment of the additional fee, the licence shall continue to be in force until orders are passed on the application and the licence shall be deemed to have expired if the application for its renewal is not made within six months of its expiry.]]138A. Application for loan licence to manufacture cosmetics.—(1) Application for grant or renewal of a loan licence for the manufacture for sale of cosmetics 2[shall be made up to ten items of each category of cosmetics categorised in Schedule MII in Form 31A to the Licensing Authority and shall be accompanied by a licence fee of rupees two thousand and five hundred and an inspection fee of rupees one thousand for every inspection thereof].Explanation.—For the purpose of this rule a ‘loan licence’ means a licence which a licensing authority may issue to an applicant who does not have his own arrangements for manufacture but who intends to avail himself of the manufacturing facilities owned by a licensee in Form 32.(2) If a person applies for the renewal of a loan licence after its expiry but within six months of such expiry, the fee payable for the renewal of such a licence shall be 2[rupees two thosuand and five hundred plus an additional fee at the rate of rupees four hundred for each month or part thereof].(3) The licensing authority shall, before the grant of a loan licence, satisfy himself that the manufacturing unit has adequate equipment, staff, capacity for manufacture and facilities to undertake the manufacture on behalf of the applicant for a loan licence.(4) The loan licence shall be granted by the licensing authority to only such applicants who propose to avail of the facilities of manufacture of cosmetics in the premises of a manufacturer located in the same State where the applicant is located. In case the manufacture of cosmetics involves any special process of manufacture or use of equipments which are not available in the State where the applicant is located, the licensing authority, after consulting the licensing authority where the manufacturing unit is located, may grant the loan licence.(5) Subject to the provisions of sub-rule (2), application for manufacture of additional items on a loan licence shall be accompanied by a fee of 2[rupees one hundred for each item subject to a maximum of rupees three thousand per application].(6) A 2[fee of rupees two hundred and fifty] shall be paid for a duplicate copy of a licence issued under sub-rule (1) if the original is defaced, damaged or lost.]1[139B. Form of loan licence to manufacture cosmetics for sale 1[or for distribution].—A loan licence to manufacture cosmetics for sale 2[or for distribution] against application in form 31A shall be granted in Form 30A.]1[141A. Certificate of renewal of loan licence.—the certificate of renewal of a licence in Form 32A shall be issued in Form 33A.]1[141AA. Duration of a loan licence.—An original loan licence in Form 32A or a renewed loan licence in Form 33A, unless sooner suspended or cancelled, shall be 2[valid for a period of five years on and from the date on which] in which it is granted or renewed:Provided that if the application for the renewal of a licence is made before its expiry, or if the application is made within six months of its expiry after payment of the additional fee, the licence shall continue to be in force until orders are passed on the application. The licence shall be deemed to have expired if the application for its renewal is not made within six months of its expiry.]1[153A. Loan Licence.—(i) An application for the grant or renewal of a loan licence to manufacture for sale of any Ayurvedic (including Siddha) or Unani drugs shall be made in Form 25E to the licensing authority along with 2[a fee of rupees six hundred].Explanation.—For the purpose of this rule, a loan licence means a licence which a licensing authority may issue to an applicant who does not have his own arrangements for manufacture but intends to avail himself of the manufacturing facilities owned by a licensee in Form 25D:Provided that in the case of renewal the applicant may apply for the renewal of the licence before its expiry or within one month of such expiry:Provided further that the applicant may apply for renewal after the expiry of one month, but within three months of such expiry in which case 3[the fee payable for renewal of such licence be rupees six hundred plus an additional fee of rupees three hundred].(ii) 4[A fee of rupees one hundred and fifty] shall be payable for a duplicate copy of a licence issued under this rule, if the original licence is defaced, damaged or lost.]1[154A. Form of loan licence to manufacture for sale Ayurvedic (including Siddha) or Unani drugs.—(1) A loan licence to manufacture for sale any Ayurvedic (including Siddha) or Unani drugs shall be issued in Form 25E.(2) A licence under this rule shall be granted by the licensing authority after consulting such expert in Ayurvedic (including Siddha) or Unani systems of medicine, as the case may be, which the State Government may approve in this behalf.(3) The licensing authority shall, before the grant of a loan licence, satisfy himself that the manufacturing unit has adequate equipment, staff, capacity for manufacture and facilities for testing, to undertake the manufacture on behalf of the applicant for a loan licence.]1[155A. Certificate of renewal of a loan licence.—The certificate of renewal of a loan licence in Form 25E shall be issued in Form 26E.]1[156A. Duration of loan licence.—An original loan licence in Form 25E or renewed loan licence in Form 26E, unless sooner suspended or cancelled, shall be 2[valid for a period of three years from the date of its issue]:Provided that if the application for the renewal of a loan licence is made in accordance with rule 153A, the loan licence shall continue to be in force until orders are passed on the application. The licence shall be deemed to have expired, if application for its renewal is not made within three month of its expiry.]1[158A. Conditions of loan licence.—A licence in Form 25E shall be subject to the following further conditions, namely:—(a) The licence in Form 25E shall be deemed to be cancelled or suspended, if the licence owned by the licensee in Form 25D whose manufacturing facilities have been availed of by the licensee is cancelled or suspended, as the case may be, under these rules.(b) The licensee shall comply with the provisions of the Act and of the rules and with such further requirements if any, as may be specified in any rules subsequently made under Chapter IVA of the Act,provided that where such further requirements are specified in the rules, these would come into force four months after publication in the Official Gazette.(c) The licensee shall maintain proper records of the details of manufacture and of the tests, if any, carried out by him, or any other person on his behalf, the raw materials and finished products.(d) The licensee shall allow an Inspector appointed under the Act to inspect all registers and records maintained under these rules and shall supply to the Inspector such information as he may require for the purpose of ascertaining whether the provisions of the Act and the rules have been observed.]2[(e) The licensee shall maintain as Inspection Book in Form 35 to enable an Inspector to record his impressions and the defects noticed.]___________1[SCHEDULE M (See rules 71, 74, 76, and 78)GOOD MANUFACTURING PRACTICES AND REQUIREMENTS OF PREMISES, PLANT AND EQUIPMENT FOR PHARMACEUTICAL PRODUCTS29.9 Loan licence manufacture and licensee (a) description of the way in which compliance of Good Manufacturing Practices by the loan licensee shall be assessed.______________________________________Guidelines For Grant Of Additional Products Permissions Under The Licence In Form-25 & FORM-28.STEP-IThe following Documents/Details To Be Submitted:1. Covering letter Addressed to the Drugs Controller and Licencing Authority for the State of Karnataka (or other state) duly signed by the applicant viz Proprietor/Partners/Managing Director/Authorized Signatory[The covering letter is an important part of the application and should clearly specify the intent of the application. The list of documents that are being submitted (Index with page number) as well as any other important and relevant information may be provided in the covering letter The covering letter should be duly signed and stamped the authorized signatory, indicating the name & designation of the authorized signatory in original issued by the Director/Company]2. Duly filled additional product proforma duly signed by the licensee viz Proprietor/Partner/Managing Director/Authorised Signatory.3 FeesFees of Rs. 300/- (for each additional product) has to be paid through challan at Government Treasury, State Bank of Mysore (or relevant other Bank for other state) under the Head of Account ‘0210 Medical and Public Health-04 Public Health-104 Fees, Fines etc.-02 Drugs and Cosmetics Act and Rules/Drugs Control Department’4 Attested true copy of the valid manufacturing licence(s).5 Declaration regarding the manufacturing facility and approved CTS for the proposed dosage form.6 Photocopy of DCG (I) permission/NOC in case of new drug.7 Photocopy of export order, rate contract order if the proposed products are required to be supplied against specific order.8 List of product/s to be manufactured In triplicate, with declaration duly signed.DownLoad Format of Declaration9 Copy of the specimen label duly signed by licencee.10 Standards & analytical procedure of each product for the patent and proprietary drugs proposed (quote the relevant authoritative books followed).11 Detail formula, shelf life, details of parallel products and packing specifications for each product.12 Details of the following:(a) Stability studies conducted and the justification for the shelf life period assigned under the conditions of storage recommended.(b) Therapeutic justification for each constituent in the product in relation to the claims made or the product is recommended for use, in case of Patent and Proprietary Medicines. (c) safety declaration as required under Rule 71(6), 71-B, 76(7), 76-A as applicable of Drugs & Cosmetics Rules depending upon the product for P & P medicines as applicable.DownLoad Safety Declaration13 Flow sheet in the case of Bulk Drugs along with the details like in process controls employed during the manufacture,14 Chemical reactions involved in the synthesis of Bulk Drug and Brief Method of Manufacture.15 Brand name declaration in the format specified duly signed by the licencee.DownLoad Brand name declaration16 Copy of the test licence in form 29 and product development data of the trial batches.17 Standards, and method of analysis of active/excipients which are not official in any pharmacopoeia.18 In case of proposed products intended to be manufactured in Principle-to-Principle basis, the photocopy of the agreement supported with trademark registration document and the copy of the whole sale Drug licence of the Third party.19 Photocopy of official monographs for the proposed product/s and its active ingredient and excipients.Download Additional Information FormNote* The above documents shall be serially numbered and to be submitted as per the sequence mentioned above.** The above requirements are not exhaustive one. In case of products of special nature/category, additional documents/ clarifications is required to be submitted whenever called for.STEP-IIThe application is verified by the manufacturing section for the correctness of the list of documents submitted and is then processed and forwarded to concerned Drugs inspector/Assistant Drugs Controller (HQ) for scrutiny and if the submitted documents are in order the application is forwarded to Drugs controller and licensing Authority through Deputy Drugs Controller (HQ) and Additional Drugs Controller for orders for the Grant of permission.STEP-IIIIf the submitted application & information is not in order or requires any clarifications a compliance letter will be served to the applicant at the level of Deputy Drugs Controller only.STEP-IVIf all documents / conditions / requirements as prescribed under the Drugs and Cosmetics Act and Rules there under and any specific office orders are complied, it is recommended by the concerned officer for grant of permission to manufacture additional product/s under the valid licence through proper channel as per the administrative order of Drugs Controller, additional product/s permission will be granted by Licensing Authority.